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1. Impact of treating iron deficiency, diagnosed according to hepcidin quantification, on outcomes after a prolonged ICU stay compared to standard care: a multicenter, randomized, single-blinded trial

Author: Sigismond Lasocki, Pierre Asfar, Samir Jaber, Martine Ferrandiere, Thomas Kerforne, Karim Asehnoune, Philippe Montravers, Philippe Seguin, Katell Peoc’h, Soizic Gergaud, Nicolas Nagot, Thibaud Lefebvre, Sylvain Lehmann, and the Hepcidane study group
Subjects: Critically ill, Anemia, Iron deficiency, Iron (treatment), Hepcidin, Mortality, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract: Abstract Background Anemia is a significant problem in patients on ICU. Its commonest cause, iron deficiency (ID), is difficult to diagnose in the context of inflammation. Hepcidin is a new marker of ID. We aimed to assess whether hepcidin levels would accurately guide treatment of ID in critically ill anemic patients after a prolonged ICU stay and affect the post-ICU outcomes. Methods In a controlled, single-blinded, multicenter study, anemic (WHO definition) critically ill patients with an ICU stay ≥ 5 days were randomized when discharge was expected to either intervention by hepcidin treatment protocol or control. In the intervention arm, patients were treated with intravenous iron (1 g of ferric carboxymaltose) when hepcidin was
Published: 2021
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2. Specific Metabolome Profile of Exhaled Breath Condensate in Patients with Shock and Respiratory Failure: A Pilot Study

Author: Brice Fermier, Hélène Blasco, Emmanuel Godat, Cinzia Bocca, Joseph Moënne-Loccoz, Patrick Emond, Christian R. Andres, Marc Laffon, and Martine Ferrandière
Subjects: metabolomics, mass spectrometry, exhaled breath condensate, biomarkers, shock, Microbiology, QR1-502
Abstract: Background: Shock includes different pathophysiological mechanisms not fully understood and remains a challenge to manage. Exhaled breath condensate (EBC) may contain relevant biomarkers that could help us make an early diagnosis or better understand the metabolic perturbations resulting from this pathological situation. Objective: we aimed to establish the metabolomics signature of EBC from patients in shock with acute respiratory failure in a pilot study. Material and methods: We explored the metabolic signature of EBC in 12 patients with shock compared to 14 controls using LC-HRMS. We used a non-targeted approach, and we performed a multivariate analysis based on Orthogonal Partial Least Square-Discriminant Analysis (OPLS-DA) to differentiate between the two groups of patients. Results: We optimized the procedure of EBC collection and LC-HRMS detected more than 1000 ions in this fluid. The optimization of multivariate models led to an excellent model of differentiation for both groups (Q2 > 0.4) after inclusion of only 6 ions. Discussion and conclusion: We validated the procedure of EBC collection and we showed that the metabolome profile of EBC may be relevant in characterizing patients with shock. We performed well in distinguishing these patients from controls, and the identification of relevant compounds may be promising for ICC patients.
Published: 2016
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3. Population pharmacokinetic/pharmacodynamic study suggests continuous infusion of ceftaroline daily dose in ventilated critical care patients with early-onset pneumonia and augmented renal clearance

Author: Alexia Chauzy, Nicolas Gregoire, Martine Ferrandière, Sigismond Lasocki, Karim Ashenoune, Philippe Seguin, Matthieu Boisson, William Couet, Sandrine Marchand, Olivier Mimoz, Claire Dahyot-Fizelier, Pharmacologie des anti-infectieux et antibiorésistance (PHAR2), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Poitiers - Faculté de Médecine et de Pharmacie, Université de Poitiers, Centre hospitalier universitaire de Poitiers (CHU Poitiers), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Pontchaillou [Rennes], and Chauzy, Alexia
Subjects: Methicillin-Resistant Staphylococcus aureus, Pharmacology, Microbiology (medical), Critical Care, Microbial Sensitivity Tests, Pneumonia, Anti-Bacterial Agents, Cephalosporins, Streptococcus pneumoniae, Infectious Diseases, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Humans, Pharmacology (medical), Renal Insufficiency, Monte Carlo Method
Abstract: Objectives Ceftaroline could be suitable to treat early-onset ventilator-associated pneumonia (VAP) because of its antibacterial spectrum. However, augmented renal clearance (ARC) is frequent in ICU patients and may affect ceftaroline pharmacokinetics and efficacy. The objective of the study was to explore the impact of ARC on ceftaroline pharmacokinetics and evaluate whether the currently recommended dosing regimen (600 mg every 12 h) is appropriate to treat VAP in ICU patients. Methods A population pharmacokinetic model was developed using pharmacokinetic data from 18 patients with measured creatinine clearance (CLCR) ranging between 83 and 309 mL/min. Monte Carlo simulations were conducted to determine the PTA and the cumulative fraction of response (CFR) against Streptococcus pneumoniae and MRSA for five dosing regimens. Study registered at ClinicalTrials.gov (NCT03025841). Results Ceftaroline clearance increased non-linearly with CLCR, with lower concentrations and lower probability of reaching pharmacokinetic/pharmacodynamic targets when CLCR increases. For the currently recommended dosing regimen, the probability of having unbound ceftaroline concentrations above the MIC over the entire dose range is greater than 90% for MICs below 0.125 mg/L. Considering the distribution of MICs, this regimen would not be effective against MRSA infections (CFR between 21% and 67% depending on CLCR), but would be effective against S. pneumoniae infections (CFR >86%). Conclusions The recommended dosing regimen of ceftaroline seems sufficient for covering S. pneumoniae in ICU patients with ARC, but not for MRSA. Among the dosing regimens tested it appears that a constant infusion (50 mg/h) after a loading dose of 600 mg could be more appropriate for MRSA infections.
Published: 2022
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4. Do Contact Precautions Reduce the Incidence of Intensive Care Unit-Acquired Pseudomonas aeruginosa Infections? The DPCPYO (Detection and Contact Precautions for Patients With P. aeruginosa) Cluster-Randomized Crossover Trial

Author: Nicolas Maillard, Jérôme Morel, Véronique Derouin, Pascal Cholley, Anne Carricajo, Laurence Drieux-Rouzet, Anne-Sylvie Dumenil, Philippe Berthelot, Nathalie van der Mee-Marquet, Alexandre Boyer, Sandra C. dos Santos, Florence Grattard, C. Slekovec, Roland Quentin, Didier Gruson, Anne-Marie Rogues, Hanaa Benmansour, Anne-Charlotte Tellier, Martine Ferrandière, Antoine Monsel, Bruno Pozzetto, Gilles Capellier, Houssein Gbaguidi-Haore, Eric Diconne, Jérôme Robert, Charlotte Arbelot, Emmanuel Samain, Xavier Bertrand, Frédéric Jacobs, Véronique Dubois, and Christelle Guillet-Caruba
Subjects: Microbiology (medical), medicine.medical_specialty, 030501 epidemiology, law.invention, 03 medical and health sciences, 0302 clinical medicine, law, Intensive care, Internal medicine, Medicine, Humans, Cumulative incidence, Pseudomonas Infections, 030212 general & internal medicine, Cross Infection, Cross-Over Studies, business.industry, Incidence (epidemiology), Incidence, Hazard ratio, Intensive care unit, Crossover study, Confidence interval, 3. Good health, Clinical trial, Intensive Care Units, Infectious Diseases, Pseudomonas aeruginosa, 0305 other medical science, business
Abstract: Background The issue of contact precautions as contributory factors for reducing Pseudomonas aeruginosa (Pa) infections in intensive care units (ICUs) remains questioned. We evaluated the impact of the addition of contact precautions to standard precautions for Pa-positive patients on incidence of ICU-acquired Pa infections. Methods In this multicenter, cluster-randomized crossover trial, 10 French ICUs were randomly assigned (1:1) to sequence 0–1 (6-month control period [CP]/3-month washout period/6-month intervention period [IP]) or sequence 1–0 (6-month IP/3-month washout period/6-month CP). A surveillance screening program for Pa was implemented. Competing-risks regression models were built with death and discharge without the occurrence of ICU-acquired Pa infection (the primary outcome) as competing events. Models were adjusted for within-ICU correlation and patient- and ICU-level covariates. The Simpson diversity index (SDI) and transmission index (TI) of Pa isolates were derived from pulsed-field gel electrophoresis typing. Results Within recruited ICUs, the cumulative incidence and incidence rate of ICU-acquired Pa infections were 3.38% (55/1625) versus 3.44% (57/1658) and 3.31 versus 3.52 per 1000 patient-days at risk during the CP and IP, respectively. Multivariable models indicated that the intervention did not significantly change the cumulative incidence (subdistribution hazard ratio, .91; 95% confidence interval [CI], .49–1.67; P = .76) or rate (cause-specific hazard ratio, 1.36; 95% CI, .71–2.63; P = .36) of the primary outcome. SDI and TI did not significantly differ between CP and IP. Conclusions The addition of contact precautions to standard precautions for Pa-positive patients with a surveillance screening program does not significantly reduce ICU-acquired Pa infections in non-outbreak situations. Clinical Trials Registration. ISRCTN92710225.
Published: 2021

5. Effect of the use of an endotracheal tube and stylet versus an endotracheal tube alone on first-attempt intubation success: a multicentre, randomised clinical trial in 999 patients

Author: Jean-Pierre Quenot, Amélie Rollé, Béatrice Riu, Alexandre Ouattara, Emmanuel Futier, Karim Asehnoune, Gerald Chanques, Piehr Saint-Léger, Claire Chauveton, Samir Jaber, Julien Pottecher, Nicolas Terzi, Laurent Muller, Raiko Blondonnet, Severin Ramin, Nicolas Molinari, Audrey De Jong, Christophe Guitton, Martine Ferrandière, Thomas Godet, Fouad Belafia, Mathieu Biais, Elie Azoulay, Helena Huguet, Jeremy Bourenne, Virginie Lemiale, Pierre Asfar, Cyril Quemeneur, Eloi Prud'Homme, Thomas Rimmelé, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier de Basse-Terre [Guadeloupe], Pôle de Médecine Périopératoire [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Centre Hospitalier Universitaire [Grenoble] (CHU), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CHU d'Angers [Département Urgences], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Hôpital de la Timone [CHU - APHM] (TIMONE), Service d'Anesthésie-Réanimation [AP-HP Hôpitaux Saint-Louis Lariboisière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Centre d'Investigation Clinique 1432 (Dijon) - Epidemiologie Clinique/Essais Cliniques (CIC-EC), Université de Bourgogne (UB)-Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service Réanimation médico-chirurgicale [CH Le Mans], Centre Hospitalier Le Mans (CH Le Mans), Service Anesthésie et Réanimation [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Centre d'études et de recherche sur les services de santé et la qualité de vie (CEReSS), Aix Marseille Université (AMU), Groupe de Recherche Clinique en Anesthésie Réanimation médecine PEriopératoire (GRC 29 - ARPE), Sorbonne Université (SU), CHU Clermont-Ferrand, Service Anesthésie - Réanimation [Bordeaux], CHU Bordeaux [Bordeaux], Université de Bordeaux Ségalen [Bordeaux 2], Unité de réanimation médicale [CHU de Carémeau, Nîmes], Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Magellan Medico-Surgical Center [Bordeaux], Adaptation cardiovasculaire à l'ischémie, Université de Bordeaux (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre hospitalier [Valenciennes, Nord], Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), Physiopathologie de l'immunodépression associée aux réponses inflammatoires systémiques / Pathophysiology of Injury-induced Immunosuppression (PI3), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, Department of Anesthesiology, Intensive care and Perioperative medicine - Hautepierre Hospital, Strasbourg, Mitochondrie, stress oxydant et protection musculaire (MSP), Université de Strasbourg (UNISTRA), Université de Montpellier (UM), Institut Montpelliérain Alexander Grothendieck (IMAG), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Hôtel-Dieu de Nantes, and Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Complications, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Critical Care and Intensive Care Medicine, Tracheal tube, Acute respiratory failure, MESH: Intubation, Intratracheal / adverse effects, law.invention, MESH: Critical illness, 03 medical and health sciences, 0302 clinical medicine, law, Intensive care, Medicine, Intubation, Stylet, Intensive care unit, ComputingMilieux_MISCELLANEOUS, MESH: Humans, business.industry, Tracheal intubation, 030208 emergency & critical care medicine, MESH: Adult, respiratory system, 3. Good health, Airway, Critical care, 030228 respiratory system, Anesthesia, Relative risk, business
Abstract: International audience; Purpose: The effect of the routine use of a stylet during tracheal intubation on first-attempt intubation success is unclear. We hypothesised that the first-attempt intubation success rate would be higher with tracheal tube + stylet than with tracheal tube alone.Methods: In this multicentre randomised controlled trial, conducted in 32 intensive care units, we randomly assigned patients to tracheal tube + stylet or tracheal tube alone (i.e. without stylet). The primary outcome was the proportion of patients with first-attempt intubation success. The secondary outcome was the proportion of patients with complications related to tracheal intubation. Serious adverse events, i.e., traumatic injuries related to tracheal intubation, were evaluated.Results: A total of 999 patients were included in the modified intention-to-treat analysis: 501 (50%) to tracheal tube + stylet and 498 (50%) to tracheal tube alone. First-attempt intubation success occurred in 392 patients (78.2%) in the tracheal tube + stylet group and in 356 (71.5%) in the tracheal tube alone group (absolute risk difference, 6.7; 95%CI 1.4-12.1; relative risk, 1.10; 95%CI 1.02-1.18; P = 0.01). A total of 194 patients (38.7%) in the tracheal tube + stylet group had complications related to tracheal intubation, as compared with 200 patients (40.2%) in the tracheal tube alone group (absolute risk difference, - 1.5; 95%CI - 7.5 to 4.6; relative risk, 0.96; 95%CI 0.83-1.12; P = 0.64). The incidence of serious adverse events was 4.0% and 3.6%, respectively (absolute risk difference, 0.4; 95%CI, - 2.0 to 2.8; relative risk, 1.10; 95%CI 0.59-2.06. P = 0.76).Conclusions: Among critically ill adults undergoing tracheal intubation, using a stylet improves first-attempt intubation success.
Published: 2021
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6. Early Changes Over Time in the Radiographic Assessment of Lung Edema Score Are Associated With Survival in ARDS

Author: Yoann Launey, Olivier Langeron, Claire Roger, Marion Monnin, M. Cisse, Julie A. Bastarache, Matthieu Jabaudon, Audrey De Jong, Emmanuel Futier, Jean-Pierre Quenot, Philippe Seguin, Mathieu Calypso, Matthieu Conseil, Benoit Veber, Garry Duclos, François Legay, Serge Molliex, Raiko Blondonnet, Julie Carr, Pablo Massanet, Mathilde Barbaz, Fabien Grelon, Jean-Etienne Bazin, Caroline Boutin, Céline Lambert, Emmanuelle Hammad, Jules Audard, Mona Assefi, Anne-Charlotte Tellier, Thomas Godet, Alexandre Lautrette, Hadanou Nanadougmar, Bernard Cosserant, Claire Dahyot-Fizelier, Charlotte Arbelot, Hervé Quintard, Jean-Yves Lefrant, Raphael Cinotti, Achile Sossou, Gerald Chanques, Martine Ferrandière, Thomas Lebouvrier, Marc Leone, Marinne Le Core, Renaud Guérin, Frank Petitas, Thomas Crozon, Edouard Lemarche, Saber Barbar, Camille Verlhac, Jean-Christophe Orban, Sigismond Lasocki, Hervé Dupont, Julien Clauzel, Jean-Michel Constantin, Fouad Belafia, Pascal Andreu, Thomas Rimmelé, Carole Ichai, Russell Chabanne, Karim Asehnoune, Jerome Morel, Antoine Roquilly, Nathanael Eisenmann, Pierre-Marie Bertrand, Samir Jaber, Auguste Dargent, Bertrand Souweine, Lorraine B. Ware, Laurent Muller, Bruno Pereira, Benjamin Cohen, Sophie Cayot, and Laurent Zieleskiewicz
Subjects: Pulmonary and Respiratory Medicine, Male, ARDS, Organ Dysfunction Scores, Pulmonary Edema, Critical Care and Intensive Care Medicine, Severity of Illness Index, survival, RALE, Radiographic Assessment of Lung Edema, 03 medical and health sciences, 0302 clinical medicine, radiographic score, medicine, Clinical endpoint, Image Processing, Computer-Assisted, Humans, 030212 general & internal medicine, Simplified Acute Physiology Score, Lung, Survival analysis, sRAGE, soluble receptor for advanced glycation end-products, Proportional Hazards Models, FACTT, Fluid and Catheter Treatment Trial, Respiratory Distress Syndrome, business.industry, Surrogate endpoint, Hazard ratio, treatable trait, LIVE, Lung Imaging for Ventilation sEtting in ARDS, Middle Aged, Pulmonary edema, medicine.disease, Prognosis, SAPS, Simplified Acute Physiology Score, Survival Analysis, HR, hazard ratio, 3. Good health, CHU, Centre Hospitalier Universitaire, Clinical trial, Radiography, Outcome and Process Assessment, Health Care, 030228 respiratory system, Anesthesia, Critical Care: Original Research, Female, Cardiology and Cardiovascular Medicine, business, Biomarkers
Abstract: Background The Radiographic Assessment of Lung Edema (RALE) score is associated with the severity of ARDS, and treatments targeted at reducing pulmonary edema such as conservative fluid management cause a reduction in RALE score over time. Research Question Are early changes in RALE score over time associated with survival in patients with ARDS? Study Design and Methods Data from patients enrolled in three centers in the Lung Imaging for Ventilation sEtting in ARDS (LIVE) trial with available chest radiographs at baseline (day 0) and days 2 or 3 were used. The RALE was scored by two independent reviewers. The primary end point was death by day 90, considering RALE score both at baseline and as a time-varying covariate in a marginal Cox survival model. Results RALE was scored from 135, 64, and 88 radiographs on days 0, 2, and 3, respectively. Both baseline RALE (hazard ratio [HR] for each one-point increment, 1.04; 95% CI, 1.01-1.08; P = .006) and the change in RALE over time (HR for each one-point decrease per unit of time, 0.99; 95% CI, 0.99-0.99; P = .03) were associated with death by day 90, even after adjustment for age, sex, BMI, Simplified Acute Physiology Score II, vasopressor use, and total volume of fluids received since study entry. Interpretation The change in RALE during the first days after ARDS onset is independently associated with survival and may be useful as a surrogate end point in future clinical trials of new therapeutics in ARDS.
Published: 2020

7. Management of liver failure in general intensive care unit

Author: Stéphanie Faure, Richard Moreau, Faouzi Saliba, E. Levesque, Philippe Ichai, Arnaud Galbois, Claire Francoz, Emmanuel Weiss, Catherine Paugam-Burtz, Martine Ferrandière, Gerald Chanques, Samir Jaber, Thomas Lescot, Stéphanie Roullet, Alexandre Louvet, Roland Amathieu, Dominique Thabut, T. Thevenot, Christophe Camus, Thierry Gustot, Lionel Velly, Christophe Bureau, C. Ichai, Service d'Anesthésie-Réanimation, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Beaujon, Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Hôpital Henri Mondor, Hôpital Claude Huriez [Lille], CHU Lille, Service d'Hépato-Gastro-Entérologie [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hospital Group Croix Saint Simon, Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse], Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées, CHU Pontchaillou [Rennes], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Centre de recherche sur l'Inflammation (CRI (UMR_S_1149 / ERL_8252 / U1149)), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Claude Galien Private Hospital, Hôpital Erasme [Bruxelles] (ULB), Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Service de Réanimation médico-chirurgicale [Nice], Hôpital Saint-Roch [Nice], Nice University Hospital, Paul-Brousse Hospital, AP-HP, CHU Saint-Antoine [AP-HP], Université de Bordeaux (UB), Centre hépato-biliaire (CHB), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Paul Brousse Hospital, AP-HP, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), University Hospital La Timone, 13005 Marseille, Institut de Neurosciences de la Timone (INT), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Beaujon Hospital, DMU Parabol, AP-HP Nord, University of Paris, Hopital Saint-Louis [AP-HP] (AP-HP), Société française d’anesthésie et de réanimation (SFAR) and the Association française pour l’étude du foie (AFEF), MORNET, Dominique, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Université de Toulouse (UT), Hôpital de la Timone [CHU - APHM] (TIMONE), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon, Hospital,Claude Huriez, Service d'Hépato-Gastroentérologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], CHU Pitié-Salpêtrière [APHP], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7)-Centre National de la Recherche Scientifique (CNRS), Erasme Hospital, Department of Gastroenterology, Saint Antoine Hospital, Assistance Publique – Hopitaux de Paris, Sorbonne Universités, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Jean Minjoz University Hospital, Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU), Hopital Saint-Louis, Assistance Publique – Hôpitaux de Paris (AP-HP), Hôpital Beaujon [AP-HP]-Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université, Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Diderot - Paris 7 (UPD7), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université, Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
Subjects: Liver Cirrhosis, medicine.medical_specialty, Cirrhosis, Consensus, Critical Care, health care facilities, manpower, and services, [SDV]Life Sciences [q-bio], Population, MEDLINE, Guidelines as Topic, Guidelines, Critical Care and Intensive Care Medicine, law.invention, 03 medical and health sciences, 0302 clinical medicine, law, Anesthesiology, Sepsis, Medicine, Humans, Intensive care unit, 030212 general & internal medicine, Intensive care medicine, education, ComputingMilieux_MISCELLANEOUS, education.field_of_study, business.industry, 030208 emergency & critical care medicine, General Medicine, Guideline, Evidence-based medicine, Sciences bio-médicales et agricoles, medicine.disease, 3. Good health, [SDV] Life Sciences [q-bio], Intensive Care Units, Acute-on-chronic liver failure, Anesthesiology and Pain Medicine, Etiology, France, business, Liver Failure, Acute liver failure
Abstract: To produce French guidelines on Management of Liver failure in general Intensive Care Unit (ICU)., info:eu-repo/semantics/published
Published: 2020
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8. Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protocol

Author: Jean-Pierre Quenot, Nicolas Grégoire, Stephan Ehrmann, Mai-Anh Nay, Benoit Veber, François Barbier, Jean-Claude Lacherade, Qin Lu, Grégoire Muller, Thierry Boulain, Julie Helms, Marie Leclerc, Pascal Andreu, Gaëtan Plantefève, Deborah Le Pennec, Renaud Respaud, Claire Dahyot-Fizelier, Elsa Tavernier, Martine Ferrandière, Gaetan Beduneau, Laurent Vecellio, Anne Veinstein, Philippe Seguin, Maria Cabrera, Hamid Merdji, David Schnell, Jean-Etienne Herbrecht, Damien Roux, Sigismond Lasocki, Ferhat Meziani, Philippe Lanotte, Mickael Landais, Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional d'Orléans (CHRO), Les Hôpitaux Universitaires de Strasbourg (HUS), Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Le Mans (CH Le Mans), Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Pontchaillou [Rennes], Centre Hospitalier d'Angoulême (CH Angoulême), Centre hospitalier universitaire de Poitiers (CHU Poitiers), CHU Rouen, Normandie Université (NU), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Service d'Anesthésie réanimation [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Centre Hospitalier Victor Dupouy, Centre d’Etude des Pathologies Respiratoires (CEPR), UMR 1100 (CEPR), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Infectiologie et Santé Publique (UMR ISP), Université de Tours-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre Hospitalier Départemental Vendée (CHDV), University Hospital of Tours, France, Programme Hospitalier de Recherche Clinique National 2015 of the French Ministry of Health (PHRC-15-260), Association pour la promotion à Tours de la Réanimation Médicale, HAL-SU, Gestionnaire, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Tours (UT)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)
Subjects: medicine.medical_specialty, medicine.medical_treatment, infectious diseases, Placebo, law.invention, respiratory infections, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, Informed consent, law, Administration, Inhalation, medicine, Humans, Multicenter Studies as Topic, Amikacin, adult intensive & critical care, Randomized Controlled Trials as Topic, Mechanical ventilation, clinical trials, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, business.industry, Intensive Care, Ventilator-associated pneumonia, Pneumonia, Ventilator-Associated, 030208 emergency & critical care medicine, General Medicine, medicine.disease, Respiration, Artificial, 3. Good health, Clinical trial, Pneumonia, Treatment Outcome, 030228 respiratory system, Emergency medicine, Medicine, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, medicine.drug
Abstract: IntroductionPre-emptive inhaled antibiotics may be effective to reduce the occurrence of ventilator-associated pneumonia among critically ill patients. Meta-analysis of small sample size trials showed a favourable signal. Inhaled antibiotics are associated with a reduced emergence of antibiotic resistant bacteria. The aim of this trial is to evaluate the benefit of a 3-day course of inhaled antibiotics among patients undergoing invasive mechanical ventilation for more than 3 days on the occurrence of ventilator-associated pneumonia.Methods and analysisAcademic, investigator-initiated, parallel two group arms, double-blind, multicentre superiority randomised controlled trial. Patients invasively ventilated more than 3 days will be randomised to receive 20 mg/kg inhaled amikacin daily for 3 days or inhaled placebo (0.9% Sodium Chloride). Occurrence of ventilator-associated pneumonia will be recorded based on a standardised diagnostic framework from randomisation to day 28 and adjudicated by a centralised blinded committee.Ethics and disseminationThe protocol and amendments have been approved by the regional ethics review board and French competent authorities (Comité de protection des personnes Ouest I, No.2016-R29). All patients will be included after informed consent according to French law. Results will be disseminated in international scientific journals.Trial registration numbersEudraCT 2016-001054-17 and NCT03149640.
Published: 2021
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9. Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial

Author: Jean-Michel Constantin, Matthieu Jabaudon, Jean-Yves Lefrant, Samir Jaber, Jean-Pierre Quenot, Olivier Langeron, Martine Ferrandière, Fabien Grelon, Philippe Seguin, Carole Ichai, Benoit Veber, Bertrand Souweine, Thomas Uberti, Sigismond Lasocki, François Legay, Marc Leone, Nathanael Eisenmann, Claire Dahyot-Fizelier, Hervé Dupont, Karim Asehnoune, Achille Sossou, Gérald Chanques, Laurent Muller, Jean-Etienne Bazin, Antoine Monsel, Lucile Borao, Jean-Marc Garcier, Jean-Jacques Rouby, Bruno Pereira, Emmanuel Futier, Cayot Sophie, Godet Thomas, Guerin Renaud, Verlac Camille, Chabanne Russel, Cosserant Bernard, Blondonnet Raiko, Lautrette Alexandre, Eisenmann Nathanael, Muller Laurent, Massanet Pablo, Boutin Caroline, Barbar Saber, Roger Claire, Belafia Fouad, Cisse Moussa, Monnin Marion, Conseil Matthieu, Carr Julie, De Jong Audrey, Dargent Auguste, Andreu Pascal, Lebouvrier Thomas, Launey Yoann, Roquilly Antoine, Cinotti Raphael, Tellier Anne-Charlotte, Barbaz Mathilde, Cohen Benjamin, Lemarche Edouard, Bertrand Pierre-Marie, Arberlot Charlotte, Zieleskiewicz Laurent, Hammad Emmanuelle, Duclos Garry, Mathie Calypso, Dupont Herve, Veber Benoit, Orban Jean-Christophe, Quintard Hervé, Rimmele Thomas, Crozon-Clauzel Julien, Le Core Marinne, Grelon Fabien, Assefi Mona, Petitas Frank, Morel Jerome, Molliex Serge, Hadanou Nanadougmar, CHU Clermont-Ferrand, Service d'Anésthésie Réanimation [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de Réanimation Médicale (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Le Mans (CH Le Mans), CHU Pontchaillou [Rennes], Nutrition, Métabolismes et Cancer (NuMeCan), Institut National de la Recherche Agronomique (INRA)-Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de réanimation, Centre Hospitalier Universitaire de Nice (CHU Nice)-Hôpital St Roch, Département d'anesthésie-Réanimation-Samu, CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Unité de soins intensifs [Clermont Ferrand], CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], Edouard Herriot Hospital, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CHU de Saint-Brieuc, Service Anesthésie et Réanimation [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Amiens-Picardie, Thérapeutiques cliniques et expérimentales des infections (EA 3826) (EA 3826), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Department of Anesthesiology and Critical Care Medicine, Emile-Roux general hospital, Le Puy-en-Velay, Université de Montpellier (UM), Immunologie - Immunopathologie - Immunothérapie (I3), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Institut Pascal (IP), SIGMA Clermont (SIGMA Clermont)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Génétique, Reproduction et Développement (GReD ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Department of Perioperative Medicine, CHU Clermont-Ferrand, CHU Pitié-Salpêtrière [APHP], Hopital Général, Le Mans, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Clermont-Ferrand-Hôpital Gabriel Montpied, Hospital General Saint-Brieuc, Hôpital Nord [CHU - APHM]-Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), Centre Régional de Lutte Contre le Cancer Jean Perrin, Centre hospitalier universitaire d'Amiens (CHU Amiens-Picardie), Service de réanimation adulte, département d'anesthésie-réanimation, CHU Clermont-Ferrand-Hôtel Dieu, Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC), University Hospital of Clermont-Ferrand, Institut Pascal - Clermont Auvergne (IP), Sigma CLERMONT (Sigma CLERMONT)-Université Clermont Auvergne (UCA)-Centre National de la Recherche Scientifique (CNRS), Unité de biostatistiques, CHU Clermont-Ferrand-Hôpital Montpied, Génétique, Reproduction et Développement - Clermont Auvergne (GReD ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA)-Centre National de la Recherche Scientifique (CNRS), MORNET, Dominique, Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])
Subjects: Pulmonary and Respiratory Medicine, Male, medicine.medical_specialty, ARDS, medicine.medical_treatment, [SDV]Life Sciences [q-bio], law.invention, Positive-Pressure Respiration, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Fraction of inspired oxygen, Intensive care, medicine, Prone Position, Tidal Volume, Humans, Single-Blind Method, 030212 general & internal medicine, Prospective Studies, Precision Medicine, Lung, Positive end-expiratory pressure, Tidal volume, ComputingMilieux_MISCELLANEOUS, Proportional Hazards Models, Mechanical ventilation, Respiratory Distress Syndrome, business.industry, Hazard ratio, Middle Aged, medicine.disease, Respiration, Artificial, 3. Good health, [SDV] Life Sciences [q-bio], Intensive Care Units, Editorial Commentary, Treatment Outcome, 030228 respiratory system, Female, France, business
Abstract: The effect of personalised mechanical ventilation on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remains uncertain and needs to be evaluated. We aimed to test whether a mechanical ventilation strategy that was personalised to individual patients' lung morphology would improve the survival of patients with ARDS when compared with standard of care.We designed a multicentre, single-blind, stratified, parallel-group, randomised controlled trial enrolling patients with moderate-to-severe ARDS in 20 university or non-university intensive care units in France. Patients older than 18 years with early ARDS for less than 12 h were randomly assigned (1:1) to either the control group or the personalised group using a minimisation algorithm and stratified according to the study site, lung morphology, and duration of mechanical ventilation. Only the patients were masked to allocation. In the control group, patients received a tidal volume of 6 mL/kg per predicted bodyweight and positive end-expiratory pressure (PEEP) was selected according to a low PEEP and fraction of inspired oxygen table, and early prone position was encouraged. In the personalised group, the treatment approach was based on lung morphology; patients with focal ARDS received a tidal volume of 8 mL/kg, low PEEP, and prone position. Patients with non-focal ARDS received a tidal volume of 6 mL/kg, along with recruitment manoeuvres and high PEEP. The primary outcome was 90-day mortality as established by intention-to-treat analysis. This study is registered online with ClinicalTrials.gov, NCT02149589.From June 12, 2014, to Feb 2, 2017, 420 patients were randomly assigned to treatment. 11 patients were excluded in the personalised group and nine patients were excluded in the control group; 196 patients in the personalised group and 204 in the control group were included in the analysis. In a multivariate analysis, there was no difference in 90-day mortality between the group treated with personalised ventilation and the control group in the intention-to-treat analysis (hazard ratio [HR] 1·01; 95% CI 0·61-1·66; p=0·98). However, misclassification of patients as having focal or non-focal ARDS by the investigators was observed in 85 (21%) of 400 patients. We found a significant interaction between misclassification and randomised group allocation with respect to the primary outcome (p0·001). In the subgroup analysis, the 90-day mortality of the misclassified patients was higher in the personalised group (26 [65%] of 40 patients) than in the control group (18 [32%] of 57 patients; HR 2·8; 95% CI 1·5-5·1; p=0·012.Personalisation of mechanical ventilation did not decrease mortality in patients with ARDS, possibly because of the misclassification of 21% of patients. A ventilator strategy misaligned with lung morphology substantially increases mortality. Whether improvement in ARDS phenotyping can decrease mortality should be assessed in a future clinical trial.French Ministry of Health (Programme Hospitalier de Recherche Clinique InterRégional 2013).
Published: 2019
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10. Effect of High-Dose Baclofen on Agitation-Related Events Among Patients With Unhealthy Alcohol Use Receiving Mechanical Ventilation

Author: Fanny Feuillet, Pierre-Joachim Mahe, Arnaud Gacouin, Adel Maamar, Mickael Vourc'h, Martine Ferrandière, Charlotte Garret, Karim Asehnoune, Maud Jonas, Jean-Claude Lacherade, Antoine Roquilly, Eric Dailly, Jean Reignier, Laurent Flet, Caroline Pouplet, Samir Jaber, and Kada Klouche
Subjects: Adult, Male, Baclofen, medicine.medical_treatment, Placebo, 01 natural sciences, law.invention, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, law, Odds Ratio, Clinical endpoint, Humans, Medicine, 030212 general & internal medicine, 0101 mathematics, Psychomotor Agitation, Aged, Mechanical ventilation, business.industry, Surrogate endpoint, 010102 general mathematics, Hazard ratio, General Medicine, Odds ratio, Length of Stay, Middle Aged, Respiration, Artificial, Intensive care unit, Alcohol-Induced Disorders, 3. Good health, Alcoholism, Intensive Care Units, GABA-B Receptor Agonists, Anesthesia, Female, business
Abstract: Importance Unhealthy alcohol use can lead to agitation in the intensive care unit (ICU). Objective To assess whether high-dose baclofen reduces agitation-related events compared with placebo in patients with unhealthy alcohol use receiving mechanical ventilation. Design, settings, and participants This phase 3, double-blind, placebo-controlled, randomized clinical trial conducted in 18 ICUs in France recruited adults receiving mechanical ventilation who met criteria for unhealthy alcohol use. Patients were enrolled from June 2016 to February 2018; the last follow-up was in May 2019. Interventions Baclofen (n = 159), adjusted from 50 to 150 mg per day based on estimated glomerular filtration rate, or placebo (n = 155) during mechanical ventilation up to a maximum of 15 days before gradual dose reduction over 3 to 6 days. Main outcomes and measures The primary end point was the percentage of patients with at least 1 agitation-related event over the treatment period. Secondary outcomes included duration of mechanical ventilation, length of ICU stay, and 28-day mortality. Results Among 314 patients who were randomized (mean age, 57 years; 60 [17.2%] women), 313 (99.7%) completed the trial. There was a statistically significant decrease in the percentage of patients who experienced at least 1 agitation-related event in the baclofen group vs the placebo group (31 [19.7%] vs 46 [29.7%]; difference, -9.93% [95% CI, -19.45% to -0.42%]; adjusted odds ratio, 0.59 [95% CI, 0.35-0.99]). Of 18 prespecified secondary end points, 14 were not significantly different. Compared with the placebo group, the baclofen group had a significantly longer median length of mechanical ventilation (9 vs 8 days; difference, 2.00 [95% CI, 0.00-3.00]; hazard ratio [HR] for extubation, 0.76 [95% CI, 0.60-0.97]) and stay in the ICU (14 vs 11 days; difference, 2.00 [95% CI, 0.00-4.00]; HR for discharge, 0.70 [95% CI, 0.54-0.90]). At 28 days, there was no significant difference in mortality in the baclofen vs placebo group (25.3% vs 21.6%; adjusted odds ratio, 1.24 [95% CI, 0.72-2.13]). Delayed awakening (no eye opening at 72 hours after cessation of sedatives and analgesics) occurred in 14 patients (8.9%) in the baclofen group vs 3 (1.9%) in the placebo group. Conclusions and relevance Among patients with unhealthy alcohol use receiving mechanical ventilation, treatment with high-dose baclofen, compared with placebo, resulted in a statistically significant reduction in agitation-related events. However, considering the modest effect and the totality of findings for the secondary end points and adverse events, further research is needed to determine the possible role of baclofen in this setting and to potentially optimize dosing. Trial registration ClinicalTrials.gov Identifier: NCT02723383.
Published: 2021
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11. Population pharmacokinetics of daptomycin in critically ill patients with various degrees of renal impairment

Author: Philippe Seguin, Karim Asehnoune, Mickael Vourc'h, Sigismond Lasocki, Sandrine Marchand, Olivier Mimoz, Mathilde Barbaz, Martine Ferrandière, William Couet, Nicolas Grégoire, Yoann Launey, Thomas Gaillard, Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Poitiers - Faculté de Médecine et de Pharmacie, Université de Poitiers, Service de Toxicologie - Pharmacocinétique [Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), Anesthésie-Réanimation 2 [CHRU Tours] (Hôpital Trousseau), Hôpital Trousseau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Pôle d'Anesthésie Réanimation, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Service d'anesthésie réanimation chirurgicale [Rennes], Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou, Service d'anesthésie et réanimation chirurgicale [Nantes], Hôtel-Dieu-Centre hospitalier universitaire de Nantes (CHU Nantes), Service d'anesthésie-réanimation [Hôtel-Dieu], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Hôtel-Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service d'anesthésie réanimation [Poitiers], Hôpital Trousseau (Tours)-Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Service d'anesthésie réanimation chirurgicale, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Hôtel-Dieu [Paris], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), and Université de Rennes (UR)-Hôpital Pontchaillou
Subjects: Male, 0301 basic medicine, health care facilities, manpower, and services, [SDV]Life Sciences [q-bio], Urine, urologic and male genital diseases, law.invention, MESH: Urine, MESH: Daptomycin, Plasma, MESH: Aged, 80 and over, law, MESH: Renal Insufficiency, Pharmacology (medical), Renal Insufficiency, Aged, 80 and over, MESH: Aged, MESH: Microbial Sensitivity Tests, MESH: Middle Aged, Middle Aged, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, Intensive care unit, Anti-Bacterial Agents, 3. Good health, Infectious Diseases, MESH: Young Adult, Toxicity, MESH: Critical Illness, Female, medicine.drug, Adult, Microbiology (medical), medicine.medical_specialty, Adolescent, Critical Illness, 030106 microbiology, Urology, Renal function, Microbial Sensitivity Tests, Biostatistics, MESH: Biostatistics, Young Adult, 03 medical and health sciences, Cmin, Daptomycin, Pharmacokinetics, MESH: Anti-Bacterial Agents, medicine, Humans, Adverse effect, MESH: Plasma, Aged, Pharmacology, MESH: Adolescent, MESH: Humans, business.industry, MESH: Adult, bacterial infections and mycoses, MESH: Male, Pharmacodynamics, business, MESH: Female
Abstract: The objective of this study was to characterize the pharmacokinetics of unbound and total concentrations of daptomycin in infected ICU patients with various degrees of renal impairment. From these results, the probability of attaining antimicrobial efficacy and the risks of toxicity were assessed.Twenty-four ICU patients with various renal functions and requiring treatment of complicated skin and soft-tissue infections, bacteraemia, or endocarditis with daptomycin were recruited. Daptomycin (Cubicin®) at 10 mg/kg was administered every 24 h for patients with creatinine clearance (CLCR) ≥30 mL/min and every 48 h for patients with CLCR30 mL/min. Total and unbound plasma concentrations and urine concentrations of daptomycin were analysed simultaneously following a population pharmacokinetic approach. Simulations were conducted to estimate the probability of attaining efficacy (unbound AUCu/MIC40 or80) or toxicity (Cmin24.3 mg/L) targets.Exposure to unbound daptomycin increased when the renal function decreased, thus increasing the probability of reaching the efficacy targets, but also the risk of toxicity. Modifications of the unbound fraction (fu) of daptomycin did not affect the pharmacokinetics of unbound daptomycin, but did affect the pharmacokinetics of total daptomycin.Daptomycin at 10 mg/kg q24h allowed efficacy pharmacokinetic/pharmacodynamic targets for ICU patients with CLCR ≥30 mL/min to be reached. For patients with CLCR30 mL/min, halving the rate of drug administration, i.e. 10 mg/kg q48h, was sufficient to reach these targets. No adverse events were observed, but the toxicity of the 10 mg/kg q24h dosing regimen should be further assessed, particularly for patients with altered renal function.
Published: 2018
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12. Sodium bicarbonate therapy for patients with severe metabolic acidaemia in the intensive care unit (BICAR-ICU): a multicentre, open-label, randomised controlled, phase 3 trial

Author: Samir Jaber, Catherine Paugam, Emmanuel Futier, Jean-Yves Lefrant, Sigismond Lasocki, Thomas Lescot, Julien Pottecher, Alexandre Demoule, Martine Ferrandière, Karim Asehnoune, Jean Dellamonica, Lionel Velly, Paër-Sélim Abback, Audrey de Jong, Vincent Brunot, Fouad Belafia, Antoine Roquilly, Gérald Chanques, Laurent Muller, Jean-Michel Constantin, Helena Bertet, Kada Klouche, Nicolas Molinari, Boris Jung, Marion Monnin, Jean-Marc Delay, Moussa Cissé, Marie Geniez, Matthieu Conseil, Bruno Souche, Jean Michel Constantin, Eric Noll, Elise Morawiec, Alexandre Robert, Thibaut Triglia, Malika Mechati, Jean-Michel Arnal, Jacques Durand-Gasselin, Didier Demoly, Sami Hraiech, Laurent Papazian, Vincent Gilles, Thomas Rimmelé, Béatrice Riu, Pierre Cougot, Olivier Fourcade, Philippe Seguin, Jonathan Charbit, Xavier Capdevila, Marc Leone, Laurent Zieleskiewicz, Carole Ichai, Jean Christophe Orban, Michael Darmon, Elie Azoulay, Virginie Lemiale, Lara Zafrani, Karim Debbat, Oliver Mimoz, Claude Guérin, Eric Kipnis, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Génétique, Reproduction et Développement (GReD), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Service d'anesthésie et réanimation chirurgicale, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Institut du Cerveau = Paris Brain Institute (ICM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Université de Strasbourg (UNISTRA), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Thérapeutiques cliniques et expérimentales des infections (EA 3826) (EA 3826), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Assistance Publique - Hôpitaux de Marseille (APHM), Hôpital Beaujon, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Clermont-Ferrand, Génétique, Reproduction et Développement - Clermont Auvergne (GReD), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire de Nîmes (CHRU Nîmes), Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute (ICM), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [APHP]-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), CHU Pitié-Salpêtrière [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon, Hôpital des Enfants Albert Royer, Laboratoire de Bactériologie, Hôpital des Enfants Albert Royer, Laboratoire de Bactériologie, Avenue Cheikh Anta Diop, Dakar, Senegal., Anesthesiology, Robert Debré Hospital, PRES Université Nantes Angers Le Mans (UNAM), Service des Soins Intensifs [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Saint-Antoine [APHP], Mitochondries, stress oxydant et protection musculaire (Strasbourg), Mitochondrie, stress oxydant et protection musculaire (MSP), Université de Strasbourg (UNISTRA)-Université de Strasbourg (UNISTRA), Sorbonne Université (SU), Service de Pneumologie et Réanimation Médicale [CHU Pitié-Salpêtrière] (Département ' R3S '), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Institut Mondor de recherche biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Conservation des espèces, restauration et suivi des populations (CERSP), Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS), Service d'anesthésie et de réanimation [Hôpital de la Timone - APHM], Hôpital de la Timone [CHU - APHM] (TIMONE), sans affiliation, Centre Hospitalier de Toulon-La Seyne, Service de réanimation-Détresses Respiratoires et Infections Sévères [Hôpital Nord - APHM] (DRIS), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, INSB-INSB-Centre National de la Recherche Scientifique (CNRS), Agressions vasculaires et réponses tissulaires, Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Toulouse [Toulouse], Service de cardiologie [Toulouse], Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Pontchaillou [Rennes], Institut des Neurosciences de Montpellier - Déficits sensoriels et moteurs (INM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Service Anesthésie et Réanimation [Hôpital Nord - APHM], Service de réanimation, Centre Hospitalier Universitaire de Nice (CHU Nice)-Hôpital St Roch, Département Imagerie et Simulation pour le Contrôle (DISC), Laboratoire d'Intégration des Systèmes et des Technologies (LIST), Direction de Recherche Technologique (CEA) (DRT (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay-Direction de Recherche Technologique (CEA) (DRT (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay, Medical ICU, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Service de réanimation médicale, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Service de Réanimation Médicale, Hôpital Saint Louis, Paris, France, Laboratoire de Géologie de Lyon - Terre, Planètes, Environnement [Lyon] (LGL-TPE), École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut national des sciences de l'Univers (INSU - CNRS)-Centre National de la Recherche Scientifique (CNRS), Université Lille 2 - Faculté de Médecine, Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)
Subjects: Bicarbonate, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Population, Metabolic alkalosis, law.invention, Cohort Studies, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, law, Intensive care, Medicine, Humans, 030212 general & internal medicine, Renal replacement therapy, education, Infusions, Intravenous, ComputingMilieux_MISCELLANEOUS, education.field_of_study, Sodium bicarbonate, business.industry, 030208 emergency & critical care medicine, General Medicine, [SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism, Hydrogen-Ion Concentration, medicine.disease, Intensive care unit, Survival Analysis, 3. Good health, Renal Replacement Therapy, Intensive Care Units, Intravenous sodium bicarbonate, Sodium Bicarbonate, chemistry, Anesthesia, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Acidosis
Abstract: Summary Background Acute acidaemia is frequently observed during critical illness. Sodium bicarbonate infusion for the treatment of severe metabolic acidaemia is a possible treatment option but remains controversial, as no studies to date have examined its effect on clinical outcomes. Therefore, we aimed to evaluate whether sodium bicarbonate infusion would improve these outcomes in critically ill patients. Methods We did a multicentre, open-label, randomised controlled, phase 3 trial. Local investigators screened eligible patients from 26 intensive care units (ICUs) in France. We included adult patients (aged ≥18 years) who were admitted within 48 h to the ICU with severe acidaemia (pH ≤7·20, PaCO2 ≤45 mm Hg, and sodium bicarbonate concentration ≤20 mmol/L) and with a total Sequential Organ Failure Assessment score of 4 or more or an arterial lactate concentration of 2 mmol/L or more. We randomly assigned patients (1:1), by stratified randomisation with minimisation via a restricted web platform, to receive either no sodium bicarbonate (control group) or 4·2% of intravenous sodium bicarbonate infusion (bicarbonate group) to maintain the arterial pH above 7·30. Our protocol recommended that the volume of each infusion should be within the range of 125–250 mL in 30 min, with a maximum of 1000 mL within 24 h after inclusion. Randomisation criteria were stratified among three prespecified strata: age, sepsis status, and the Acute Kidney Injury Network (AKIN) score. The primary outcome was a composite of death from any cause by day 28 and the presence of at least one organ failure at day 7. All analyses were done on data from the intention-to-treat population, which included all patients who underwent randomisation. This study is registered with ClinicalTrials.gov, number NCT02476253. Findings Between May 5, 2015, and May 7, 2017, we enrolled 389 patients into the intention-to-treat analysis in the overall population (194 in the control group and 195 in the bicarbonate group). The primary outcome occurred in 138 (71%) of 194 patients in the control group and 128 (66%) of 195 in the bicarbonate group (absolute difference estimate −5·5%, 95% CI −15·2 to 4·2; p=0·24). The Kaplan-Meier method estimate of the probability of survival at day 28 between the control group and bicarbonate group was not significant (46% [95% CI 40–54] vs 55% [49–63]; p=0·09. In the prespecified AKIN stratum of patients with a score of 2 or 3, the Kaplan-Meier method estimate of survival by day 28 between the control group and bicarbonate group was significant (37% [95% CI 28–48] vs 54% [45–65]; p=0·0283). Metabolic alkalosis, hypernatraemia, and hypocalcaemia were observed more frequently in the bicarbonate group than in the control group, with no life-threatening complications reported. Interpretation In patients with severe metabolic acidaemia, sodium bicarbonate had no effect on the primary composite outcome. However, sodium bicarbonate decreased the primary composite outcome and day 28 mortality in the a-priori defined stratum of patients with acute kidney injury. Funding French Ministry of Health and the Societe Francaise d'Anesthesie Reanimation.
Published: 2018
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13. Fungal complications afterCandidapreservation fluid contamination in liver transplant recipients

Author: Liliana Mihaila, J.-C. Merle, Laurent Stecken, Eric Levesque, Linda Khoy-Ear, Catherine Paugam-Burtz, Martine Ferrandière, Boris Jung, Faouzi Saliba, Françoise Botterel, Centre hépato-biliaire - CHB [Paul Brousse, Paris], Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse, département d'anesthésiologie, Foie ICU, AP-HP GH Henri Mondor, Créteil, France, Hôpital Beaujon, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Diderot - Paris 7 (UPD7), Centre hépato-biliaire (CHB), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Département d'anesthésiologie, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Bordeaux [Bordeaux], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Unité de Microbiologie, G.H. Kremlin-Bicetre, Kremlin-Bicetre, France, Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Université Paris-Sud - Paris 11 (UP11)-AP-HP Hôpital Paul Brousse, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Paul Brousse-Université Paris-Sud - Paris 11 (UP11), Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), and Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Male, Antifungal Agents, [SDV]Life Sciences [q-bio], medicine.medical_treatment, preservation fluid, 030230 surgery, Liver transplantation, Gastroenterology, Hepatic Artery, 0302 clinical medicine, Risk Factors, Postoperative Period, Candida albicans, Candida, Aged, 80 and over, liver transplantation, biology, Mortality rate, Incidence (epidemiology), Candidiasis, Middle Aged, 3. Good health, Research Design, Female, 030211 gastroenterology & hepatology, France, Immunosuppressive Agents, Adult, medicine.medical_specialty, Organ Preservation Solutions, Peritonitis, Context (language use), Young Adult, 03 medical and health sciences, Internal medicine, medicine, Humans, Clinical significance, Aged, Retrospective Studies, Transplantation, business.industry, fungal infection, medicine.disease, biology.organism_classification, Transplant Recipients, Surgery, aneurysm, Equipment Contamination, business, Complication, Liver Failure
Abstract: International audience; Donor-derived fungal infections can be associated with severe complications in transplant recipients. Donor-derived candidiasis has been described in kidney transplant recipients where contamination of the preservation fluid (PF) was a commonly proposed source. In liver transplantation, these fungal infections have been less explored. The aim of this study was therefore to determine the incidence and clinical relevance of Candida contamination of preservation fluid in the context of liver transplantation. A 5-year (2008-2012) retrospective multicentre study involving six French liver transplantation centers was performed to determine the incidence of Candida PF contamination. Postoperative clinical features, outcomes in recipients, and risk factors for Candida-related complications of liver transplantation were studied. Candida sp. was isolated from 28 of 2107 preservation fluid samples (1.33%). Candida albicans was the most common yeast (n = 18, 64%). Twenty-two recipients (78.5%) received antifungal therapy (echinocandins in 68%) for 7-37 days. Eight patients developed yeast-related complications (28.6%) including hepatic artery aneurysms (n = 6) and Candida peritonitis (n = 2). The 1-year mortality rate among patients after a yeast-related complication was 62.5%. The incidence of Candida PF contamination was low, but was associated with dramatic postoperative complications and high mortality. Close radiological follow-up may enable early recognition of the arterial complications associated with PF contamination by Candida.
Published: 2015
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14. Modulation by Polymyxin-B Hemoperfusion of Inflammatory Response Related to Severe Peritonitis

Author: Stéphanie Chevalier, Martine Ferrandière, Matthieu Jabaudon, Thomas Kerforne, Carlos Vela, Laurent Martin-Lefevre, Antoine Dewitte, Eric Kipnis, Olivier Collange, Anne-Claire Lukaszewicz, Rémi Coudroy, Didier Payen, Benoit Veber, Jean-Claude Lecron, Mahmoud Kaaki, Jihad Mallat, René Robert, Sandrine Charreau, Yoann Launey, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Department of anesthesiology and intensive care, Hôpitaux Universitaires Saint-Louis, Lariboisière, Fernand-Widal, Department of anesthesiology and critical care medicine, Hôpitaux Universitaire Saint-Louis, Lariboisière, Fernand-Widal, Alloimmunité-Autoimmunité-Transplantation (A2T), Institut Universitaire d'Hématologie (IUH), Université Paris Diderot - Paris 7 (UPD7)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Service d'Anesthésie et Soins Intensifs, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Microcirculation, bioénergétique, inflammation et insuffisance circulatoire aiguë (URCT), Université Paris-Sud - Paris 11 (UP11)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris 13 (UP13)-Université Sorbonne Paris Cité (USPC), Service de réanimation médicale [CHU Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Services de soins intensifs, CHU Strasbourg, Département d'Anesthésie et Réanimation Chirurgicale [Poitiers], Ischémie Reperfusion en Transplantation d’Organes Mécanismes et Innovations Thérapeutiques ( IRTOMIT), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Université Lille 2 - Faculté de Médecine, Laboratoire Inflammation, Tissus épithéliaux et Cytokines (LITEC), Université de Poitiers, Institut Français de Recherche pour l'Exploitation de la Mer - Brest (IFREMER Centre de Bretagne), Institut Français de Recherche pour l'Exploitation de la Mer (IFREMER), Université Paris 13 (UP13)-Université Paris-Sud - Paris 11 (UP11)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC), Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Faculté de Médecine Henri Warembourg - Université de Lille, and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Poitiers
Subjects: Male, 0301 basic medicine, medicine.medical_specialty, medicine.medical_treatment, Population, Peritonitis, [SDV.CAN]Life Sciences [q-bio]/Cancer, Critical Care and Intensive Care Medicine, Systemic inflammation, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, education, Aged, Polymyxin B, education.field_of_study, Interleukin-6, Tumor Necrosis Factor-alpha, Septic shock, business.industry, Standard treatment, Interleukin-17, 030208 emergency & critical care medicine, Middle Aged, [SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism, medicine.disease, Hemoperfusion, Shock, Septic, Interleukin-10, 3. Good health, 030104 developmental biology, Cytokine, Emergency Medicine, Female, medicine.symptom, business, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, medicine.drug
Abstract: International audience; Conflicting results have been reported on the influence of Polymyxin-B hemoperfusion treatment on systemic inflammation markers. The aim of the study was to assess in a randomized control trial the influence on plasma cytokine concentrations of Polymyxin-B hemoperfusion in septic shock due to peritonitis. A panel of 10 pro- or anti-inflammatory cytokines was measured in 213 patients with peritonitis-induced septic shock enrolled in the randomized trial ABDOMIX testing the impact of 2 Polymyxin-B hemoperfusion sessions with standard treatment. Gram-negative bacteria were identified in 69% of patients. In the overall population, baseline plasma cytokine concentrations were not different between the two groups. Circulating tumor necrosis factor-α, interleukin (IL)-1β, IL-10, IL-6, and IL-1RA decreased significantly over time in both groups (P
Published: 2017
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15. Non-invasive ventilation corrects alveolar hypoventilation during spinal anesthesia

Author: Martine Ferrandière, E. Hazouard, John Gage, Jacques Fusciardi, Marc Laffon, Jean Ayoub, and Colette Mercier
Subjects: Male, Diaphragm, Hypoventilation, General Medicine, Middle Aged, Anesthesia, Spinal, Obesity, Morbid, Positive-Pressure Respiration, Pulmonary Alveoli, Pulmonary Disease, Chronic Obstructive, Anesthesiology and Pain Medicine, Humans, Hypoxia, Intraoperative Complications, Ultrasonography
Abstract: To document and explain the beneficial effects of non-invasive ventilation in correcting hypoxemia and hypoventilation in severe chronic obstructive pulmonary disease, during spinal anesthesia in the lithotomy position.A morbidly obese patient with severe chronic obstructive pulmonary disease underwent prostate surgery in the lithotomy position under spinal anesthesia. Hypoxemia was encountered during surgery, and a profound decrease of forced vital capacity associated with alveolar hypoventilation and ventilation/perfusion mismatching were observed. In the operating room, an M-mode sonographic study of the right diaphragm was performed, which confirmed that after spinal anesthesia and assuming the lithotomy position, there was a large decrease (-30%) in diaphragmatic excursion. Hypoxemia and alveolar hypoventilation were successfully treated with non-invasive positive pressure ventilation.Intraoperative application of non-invasive positive pressure ventilation improved diaphragmatic excursion and overall respiratory function, and reduced clinical discomfort in this patient.
Published: 2006
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16. Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial

Author: Didier M, Payen, Joelle, Guilhot, Yoann, Launey, Anne Claire, Lukaszewicz, Mahmoud, Kaaki, Benoit, Veber, Julien, Pottecher, Olivier, Joannes-Boyau, Laurent, Martin-Lefevre, Matthieu, Jabaudon, Olivier, Mimoz, Rémi, Coudroy, Martine, Ferrandière, Eric, Kipnis, Carlos, Vela, Stéphanie, Chevallier, Jihad, Mallat, René, Robert, P, Rigaud, Service d'Anesthésie-Réanimation [AP-HP Hôpitaux Saint-Louis Lariboisière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Ecotaxie, microenvironnement et développement lymphocytaire (EMily (UMR_S_1160 / U1160)), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Centre Hospitalier de Roanne, Service de réanimation médicale [CHU Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Université de Strasbourg (UNISTRA), CHU Bordeaux [Bordeaux], Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, CHU Clermont-Ferrand, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Poitiers - Faculté de Médecine et de Pharmacie, Université de Poitiers, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Université Lille 2 - Faculté de Médecine, Hôpital Claude Huriez [Lille], CHU Lille, Centre Hospitalier Saint Jean de Perpignan, Centre hospitalier de Saint-Malo, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Lariboisière-Université Paris Diderot - Paris 7 (UPD7), Service de réanimation médicale [Rouen], Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU)-Hôpital Charles Nicolle [Rouen], Hôpital Claude Huriez, and Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)
Subjects: Adult, Male, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Multiple Organ Failure, Peritonitis, Critical Care and Intensive Care Medicine, law.invention, Young Adult, Seven-Day Profile Publication, Randomized controlled trial, law, Septic shock, medicine, Humans, Prospective Studies, Mortality, Prospective cohort study, Aged, Polymyxin B, Aged, 80 and over, business.industry, Abdominal Infection, Hemodynamics, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, Middle Aged, medicine.disease, Hemoperfusion, Shock, Septic, 3. Good health, Anti-Bacterial Agents, Shock (circulatory), Anesthesia, Female, medicine.symptom, business, medicine.drug
Abstract: Purpose To test whether the polymyxin B hemoperfusion (PMX HP) fiber column reduces mortality and organ failure in peritonitis-induced septic shock (SS) from abdominal infections. Method Prospective, multicenter, randomized controlled trial in 18 French intensive care units from October 2010 to March 2013, enrolling 243 patients with SS within 12 h after emergency surgery for peritonitis related to organ perforation. The PMX HP group received conventional therapy plus two sessions of PMX HP. Primary outcome was mortality on day 28; secondary outcomes were mortality on day 90 and a reduction in the severity of organ failures based on Sequential Organ Failure Assessment (SOFA) scores. Results Primary outcome: day 28 mortality in the PMX HP group (n = 119) was 27.7 versus 19.5 % in the conventional group (n = 113), p = 0.14 (OR 1.5872, 95 % CI 0.8583–2.935). Secondary endpoints: mortality rate at day 90 was 33.6 % in PMX-HP versus 24 % in conventional groups, p = 0.10 (OR 1.6128, 95 % CI 0.9067–2.8685); reduction in SOFA score from day 0 to day 7 was −5 (−11 to 6) in PMX-HP versus −5 (−11 to 9), p = 0.78. Comparable results were observed in the predefined subgroups (presence of comorbidity; adequacy of surgery
Published: 2014
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17. Discriminating between the activities of human neutrophil elastase and proteinase 3 using serpin-derived fluorogenic substrates

Author: Luiz Juliano, Martine Ferrandière, Francis Gauthier, Marie Lise Jourdan, E. Hazouard, Brice Korkmaz, Sylvie Attucci, and Michèle Brillard-Bourdet
Subjects: Proteases, Neutrophils, medicine.medical_treatment, Myeloblastin, Molecular Sequence Data, Serpin, Cathepsin G, Sodium Chloride, Biochemistry, Substrate Specificity, chemistry.chemical_compound, Viral Proteins, Proteinase 3, medicine, Humans, Amino Acid Sequence, Amino Acids, Molecular Biology, Chromatography, High Pressure Liquid, Serpins, Protease, biology, Sequence Homology, Amino Acid, Hydrolysis, Elastase, Serine Endopeptidases, Cell Biology, Flow Cytometry, Molecular biology, Kinetics, chemistry, Neutrophil elastase, Plasminogen activator inhibitor-1, biology.protein, Leukocytes, Mononuclear, Leukocyte Elastase, Peptides, Protein Binding
Abstract: Human neutrophil elastase (HNE) has long been linked to the pathology of a variety of inflammatory diseases and therefore is a potential target for therapeutic intervention. At least two other serine proteases, proteinase 3 (Pr3) and cathepsin G, are stored within the same neutrophil primary granules as HNE and are released from the cell at the same time at inflammatory sites. HNE and Pr3 are structurally and functionally very similar, and no substrate is currently available that is preferentially cleaved by Pr3 rather than HNE. Discrimination between these two proteases is the first step in elucidating their relative contributions to the development and spread of inflammatory diseases. Therefore, we have prepared new fluorescent peptidyl substrates derived from natural target proteins of the serpin family. This was done because serpins are rapidly cleaved within their reactive site loop whether they act as protease substrates or inhibitors. The hydrolysis of peptide substrates reflects the specificity of the parent serpin including those from alpha-1-protease inhibitor and monocyte neutrophil elastase inhibitor, two potent inhibitors of elastase and Pr3. More specific substrates for these proteases were derived from the reactive site loop of plasminogen activator inhibitor 1, proteinase inhibitors 6 and 9, and from the related viral cytokine response modifier A (CrmA). This improved specificity was obtained by using a cysteinyl residue at P1 for Pr3 and an Ile residue for HNE and because of occupation of protease S' subsites. These substrates enabled us to quantify nanomolar concentrations of HNE and Pr3 that were free in solution or bound at the neutrophil surface. As membrane-bound proteases resist inhibition by endogenous inhibitors, measuring their activity at the surface of neutrophils may be a great help in understanding their role during inflammation.
Published: 2002

18. Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protocol

Author: Sigismond Lasocki, Claire Dahyot-fizelier, Benoit Veber, Damien Roux, Stephan Ehrmann, Jean-Pierre Quenot, Thierry Boulain, Mai-Anh Nay, Elsa Tavernier, Gaetan Beduneau, Philippe Seguin, Jean-Claude Lacherade, Grégoire Muller, Maria Cabrera, Gaetan Plantefeve, Mickael Landais, Nicolas Grégoire, Francois Barbier, Ferhat Meziani, Jean-Etienne Herbrecht, David Schnell, Anne Veinstein, Qin Lu, Martine Ferrandiere, Hamid Merdji, Pascal Andreu, Laurent Vecellio, Deborah Le Pennec, Renaud Respaud, Philippe Lanotte, Marie Leclerc, and Julie Helms
Subjects: Medicine
Abstract: Introduction Pre-emptive inhaled antibiotics may be effective to reduce the occurrence of ventilator-associated pneumonia among critically ill patients. Meta-analysis of small sample size trials showed a favourable signal. Inhaled antibiotics are associated with a reduced emergence of antibiotic resistant bacteria. The aim of this trial is to evaluate the benefit of a 3-day course of inhaled antibiotics among patients undergoing invasive mechanical ventilation for more than 3 days on the occurrence of ventilator-associated pneumonia.Methods and analysis Academic, investigator-initiated, parallel two group arms, double-blind, multicentre superiority randomised controlled trial. Patients invasively ventilated more than 3 days will be randomised to receive 20 mg/kg inhaled amikacin daily for 3 days or inhaled placebo (0.9% Sodium Chloride). Occurrence of ventilator-associated pneumonia will be recorded based on a standardised diagnostic framework from randomisation to day 28 and adjudicated by a centralised blinded committee.Ethics and dissemination The protocol and amendments have been approved by the regional ethics review board and French competent authorities (Comité de protection des personnes Ouest I, No.2016-R29). All patients will be included after informed consent according to French law. Results will be disseminated in international scientific journals.Trial registration numbers EudraCT 2016-001054-17 and NCT03149640.
Published: 2021
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18 results on '"Martine Ferrandière"'

1. Impact of treating iron deficiency, diagnosed according to hepcidin quantification, on outcomes after a prolonged ICU stay compared to standard care: a multicenter, randomized, single-blinded trial

2. Specific Metabolome Profile of Exhaled Breath Condensate in Patients with Shock and Respiratory Failure: A Pilot Study

3. Population pharmacokinetic/pharmacodynamic study suggests continuous infusion of ceftaroline daily dose in ventilated critical care patients with early-onset pneumonia and augmented renal clearance

4. Do Contact Precautions Reduce the Incidence of Intensive Care Unit-Acquired Pseudomonas aeruginosa Infections? The DPCPYO (Detection and Contact Precautions for Patients With P. aeruginosa) Cluster-Randomized Crossover Trial

5. Effect of the use of an endotracheal tube and stylet versus an endotracheal tube alone on first-attempt intubation success: a multicentre, randomised clinical trial in 999 patients

6. Early Changes Over Time in the Radiographic Assessment of Lung Edema Score Are Associated With Survival in ARDS

7. Management of liver failure in general intensive care unit

8. Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protocol

9. Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial

10. Effect of High-Dose Baclofen on Agitation-Related Events Among Patients With Unhealthy Alcohol Use Receiving Mechanical Ventilation

11. Population pharmacokinetics of daptomycin in critically ill patients with various degrees of renal impairment

12. Sodium bicarbonate therapy for patients with severe metabolic acidaemia in the intensive care unit (BICAR-ICU): a multicentre, open-label, randomised controlled, phase 3 trial

13. Fungal complications afterCandidapreservation fluid contamination in liver transplant recipients

14. Modulation by Polymyxin-B Hemoperfusion of Inflammatory Response Related to Severe Peritonitis

15. Non-invasive ventilation corrects alveolar hypoventilation during spinal anesthesia

16. Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial

17. Discriminating between the activities of human neutrophil elastase and proteinase 3 using serpin-derived fluorogenic substrates

18. Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protocol

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18 results on '"Martine Ferrandière"'

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