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18 results on '"Le Gouge, Amelie"'

1. Can Biomarkers Correctly Predict Ventilator-associated Pneumonia in Patients Treated With Targeted Temperature Management After Cardiac Arrest? An Exploratory Study of the Multicenter Randomized Antibiotic (ANTHARTIC) Study

Author

Deye, Nicolas, Le Gouge, Amelie, François, Bruno, Chenevier-Gobeaux, Camille, Daix, Thomas, Merdji, Hamid, Cariou, Alain, Dequin, Pierre-François, Guitton, Christophe, Mégarbane, Bruno, Callebert, Jacques, Giraudeau, Bruno, Mebazaa, Alexandre, and Vodovar, Nicolas

Published
2024
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3. Low versus standard calorie and protein feeding in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3)

Author

Contou, Damien, Pajot, Olivier, Jaubert, Paul, Marin, Nathalie, Simon, Marie, Cour, Martin, Mortaza, Satar, Souday, Vincent, Lemerle, Marie, Malfroy, Sylvain, Berdaguer Ferrari, Fernando, Rozec, Bertrand, Gruson, Didier, Sazio, Charline, Champion, Suzanne, Boissier, Florence, Veinstein, Anne, Baboi, Loredana, Richard, Jean-Christophe, Yonis, Hodane, Le Guennec, Loïc, Lefevre, Lucie, Chommeloux, Juliette, Hékimian, Guillaume, Lemiale, Virginie, Mariotte, Eric, Valade, Sandrine, Tirolien, Joanna, Fedun, Yannick, Cerf, Charles, Tachon, Guillaume, Roustan, Jérôme, Vimeux, Sylvie, Bonnivard, Michel, Anguel, Nadia, Osman, David, Asehnoune, Karim, Roquilly, Antoine, Belafia, Fouad, Conseil, Matthieu, Cisse, Moussa, Chaouki, Bouras, Espenel, Rémi, Brasse, Christine, Ena, Sébastien, Delahaye, Arnaud, Castanera, Jeremy, Dulac, Thierry, Petua, Philippe, Zerbib, Yoann, Brault, Clément, Annane, Djillali, Bounab, Rania, Heming, Nicholas, Boulain, Thierry, Jacquier, Sophie, Muller, Grégoire, Favory, Raphael, Préau, Sébastien, Poissy, Julien, Massri, Alexandre, Lissonde, Floriane, Winiszewski, Hadrien, Vieille, Thibault, Jacquier, Marine, Labruyère, Marie, Andreu, Pascal, Tadié, Jean-Marc, Bodenes, Laetitia, Combaux, Danièle, Luis, David, Marchalot, Antoine, Herbrecht, Jean-Etienne, Clere-Jehl, Raphaël, Schnell, David, Aboad, Jérôme, Bougon, David, Escudier, Etienne, Coupez, Elisabeth, Dupuis, Claire, Demailly, Zoe, Galerneau, Louis-Marie, Chelly, Jonathan, Pourcine, Franck, Van Vong, Ly, Abid, Sonia, De Montmollin, Etienne, Sonneville, Romain, Guitton, Christophe, Chudeau, Nicolas, Landais, Mickaël, Pages, Vincent, Séjourné, Caroline, Rahmani, Imen, Sbouj, Ghada, Megarbane, Bruno, Deye, Nicolas, Malissin, Isabelle, Reignier, Jean, Plantefeve, Gaetan, Mira, Jean-Paul, Argaud, Laurent, Asfar, Pierre, Aissaoui, Nadia, Badie, Julio, Botoc, Nicolae-Vlad, Brisard, Laurent, Bui, Hoang-Nam, Chatellier, Delphine, Chauvelot, Louis, Combes, Alain, Cracco, Christophe, Darmon, Michael, Das, Vincent, Debarre, Matthieu, Delbove, Agathe, Devaquet, Jérôme, Dumont, Louis-Marie, Gontier, Olivier, Groyer, Samuel, Guérin, Laurent, Guidet, Bertrand, Hourmant, Yannick, Jaber, Samir, Lambiotte, Fabien, Leroy, Christophe, Letocart, Philippe, Madeux, Benjamin, Maizel, Julien, Martinet, Olivier, Martino, Frédéric, Maxime, Virginie, Mercier, Emmanuelle, Nay, Mai-Anh, Nseir, Saad, Oziel, Johanna, Picard, Walter, Piton, Gael, Quenot, Jean-Pierre, Reizine, Florian, Renault, Anne, Richecoeur, Jack, Rigaud, Jean-Philippe, Schneider, Francis, Silva, Daniel, Sirodot, Michel, Souweine, Bertrand, Tamion, Fabienne, Terzi, Nicolas, Thévenin, Didier, Thiery, Guillaume, Thieulot-Rolin, Nathalie, Timsit, Jean-Francois, Tinturier, Francois, Tirot, Patrice, Vanderlinden, Thierry, Vinatier, Isabelle, Vinsonneau, Christophe, Voicu, Sebastian, Lascarrou, Jean-Baptiste, and Le Gouge, Amélie

Published
2023
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5. Predicting individualized treatment effects of corticosteroids in community-acquired-pneumonia: a data-driven analysis of randomized controlled trials

Author

Smit, Jim M., primary, van der Zee, Philip A., additional, Stoof, S. C.M., additional, van Genderen, Michel E., additional, Snijders, Dominic, additional, Boersma, Wim G., additional, Confalonieri, Paola, additional, Salton, Francesco, additional, Confalonieri, Marco, additional, Shih, Mei-Chiung, additional, Meduri, Gianfranco U., additional, Dequin, Pierre-Francois, additional, Le Gouge, Amelie, additional, Lloyd, Melanie, additional, Karunajeewa, Harin, additional, Bartminski, Grzegorz, additional, Fernandez-Serrano, Silvia, additional, Suarez-Cuartin, Guillermo, additional, van Klaveren, David, additional, Briel, Matthias, additional, Schoenenberger, Christof M., additional, Steyerberg, Ewout W., additional, Gommers, Diederik A.M.P.J., additional, Bax, Hannelore I., additional, Bos, W J W., additional, van de Garde, Ewoudt, additional, Wittermans, Esther, additional, Grutters, Jan C., additional, Blum, Claudine A., additional, Christ-Crain, Mirjam, additional, Torres, Antoni, additional, Motos, Anna, additional, Reinders, Marcel J.T., additional, van Bommel, Jasper, additional, Krijthe, Jesse H., additional, and Endeman, Henrik, additional

Published
2023
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6. Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2)

Author

Dupont, Hervé, Pierrot, Marc, Beloncle, François, Combaux, Danièle, Mercier, Romain, Winiszewski, Hadrien, Capellier, Gilles, Hilbert, Gilles, Gruson, Didier, Kalfon, Pierre, Souweine, Bertrand, Coupez, Elizabeth, Ricard, Jean-Damien, Messika, Jonathan, Bougerol, François, Declercq, Pierre-Louis, Dargent, Auguste, Large, Audrey, Annane, Djillali, Clair, Bernard, Bonadona, Agnès, Hamidfar, Rebecca, Richard, Christian, Henry-Lagarrigue, Mathieu, Yehia, Ahiem Yehia, Temime, Johanna, Barrailler, Stephanie, Favory, Raphaël, Parmentier-Decrucq, Erika, Jourdain, Mercé, Baboi, Loredana, Simon, Marie, Baudry, Thomas, Monchi, Mehran, Roustan, Jérôme, Bardou, Patrick, Cottereau, Alice, Guiot, Philippe, Brule, Noelle, Landais, Mickael, Roquilly, Antoine, Boulain, Thierry, Benzekri, Dalila, Champigneulle, Benoit, Tahiri, Jalel, Preda, Gabriel, Misset, Benoit, Lemiale, Virginie, Zafrani, Lara, Fartoukh, Muriel, Thiéry, Guillaume, Chatellier, Delphine, Coudroy, Rémi, Chouquer, Renaud, Gay, Samuel, Brasse, Christine, Delahaye, Arnaud, Ferreira, Luis, Vermesch, Régine, Chevalier, Stéphanie, Quentin, Charlotte, Maestraggi, Quentin, Schneider, Francis, Meziani, Ferhat, Cerf, Charles, Trebbia, Grégoire, Salmon-Gandonnière, Charlotte, Bodet-Contentin, Laetitia, Reignier, Jean, Boisramé-Helms, Julie, Brisard, Laurent, Lascarrou, Jean-Baptiste, Ait Hssain, Ali, Anguel, Nadia, Argaud, Laurent, Asehnoune, Karim, Asfar, Pierre, Bellec, Frédéric, Botoc, Vlad, Bretagnol, Anne, Bui, Hoang-Nam, Canet, Emmanuel, Da Silva, Daniel, Darmon, Michael, Das, Vincent, Devaquet, Jérôme, Djibre, Michel, Ganster, Frédérique, Garrouste-Orgeas, Maité, Gaudry, Stéphane, Gontier, Olivier, Guérin, Claude, Guidet, Bertrand, Guitton, Christophe, Herbrecht, Jean-Etienne, Lacherade, Jean-Claude, Letocart, Philippe, Martino, Frédéric, Maxime, Virginie, Mercier, Emmanuelle, Mira, Jean-Paul, Nseir, Saad, Piton, Gael, Quenot, Jean-Pierre, Richecoeur, Jack, Rigaud, Jean-Philippe, Robert, René, Rolin, Nathalie, Schwebel, Carole, Sirodot, Michel, Tinturier, François, Thévenin, Didier, Giraudeau, Bruno, and Le Gouge, Amélie

Published
2018
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7. Low-dose aspirin to prevent preeclampsia and growth restriction in nulliparous women identified by uterine artery Doppler as at high risk of preeclampsia: A double blinded randomized placebo-controlled trial

Author

Diguisto, Caroline, Le Gouge, Amelie, Marchand, Marie-Sara, Megier, Pascal, Ville, Yves, Haddad, Georges, Winer, Norbert, Arthuis, Chloé, Doret, Muriel, Debarge, Veronique Houfflin, Flandrin, Anaig, Delmas, Hélène Laurichesse, Gallot, Denis, Mares, Pierre, Vayssiere, Christophe, Sentilhes, Loïc, Cheve, Marie-Therese, Paumier, Anne, Durin, Luc, Schaub, Bruno, Equy, Veronique, Giraudeau, Bruno, Perrotin, Franck, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Maternité Olympe de Gouges [CHRU Tours], Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), 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), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Régional d'Orléans (CHRO), CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Descartes - Paris 5 (UPD5), Physiopathologie des Adaptations Nutritionnelles (PhAN), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ), Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Femme Mère Enfant [CHU - HCL] (HFME), Hospices Civils de Lyon (HCL), CHU Lille, Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Arnaud de Villeneuve [CHRU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Clermont-Ferrand, Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Aix-Marseille Université - École de maïeutique (AMU SMPM EM), Aix-Marseille Université - Faculté des sciences médicales et paramédicales (AMU SMPM), Aix Marseille Université (AMU)-Aix Marseille Université (AMU), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Hôpital Pellegrin, CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, Centre Hospitalier Le Mans (CH Le Mans), Polyclinique de l’Atlantique, Partenaires INRAE, Elsan Polyclinique du Parc - Caen, CHU de la Martinique [Fort de France], CHU Grenoble, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble, and Université de Tours (UT)

Subjects
Male, Uterine Artery, Pregnancy Trimester, First, Multidisciplinary, Pre-Eclampsia, Aspirin, Pregnancy, [SDV]Life Sciences [q-bio], Infant, Newborn, Humans, Birth Weight, Female
Abstract

Introduction This trial evaluates whether daily low-dose aspirin initiated before 16 weeks of gestation can reduce preeclampsia and fetal growth restriction in nulliparous women identified by first-trimester uterine artery Dopplers as at high risk of preeclampsia. Methods This randomized, blinded, placebo-controlled, parallel-group trial took place in 17 French obstetric departments providing antenatal care. Pregnant nulliparous women aged ≥ 18 years with a singleton pregnancy at a gestational age < 16 weeks of gestation with a lowest pulsatility index ≥ 1.7 or a bilateral protodiastolic notching for both uterine arteries on an ultrasound performed between 11+0 and 13+6 weeks by a certified sonographer were randomized at a 1:1 ratio to 160 mg of low-dose aspirin or to placebo to be taken daily from inclusion to their 34th week of gestation. The main outcome was preeclampsia or a birthweight ≤ 5th percentile. Other outcomes included preeclampsia, severe preeclampsia, preterm preeclampsia, preterm delivery before 34 weeks, mode of delivery, type of anesthesia, birthweight ≤ 5th percentile and perinatal death. Results The trial was interrupted due to recruiting difficulties. Between June 2012 and June 2016, 1104 women were randomized, two withdrew consent, and two had terminations of pregnancies. Preeclampsia or a birthweight ≤ 5th percentile occurred in 88 (16.0%) women in the low-dose aspirin group and in 79 (14.4%) in the placebo group (proportion difference 1.6 [-2.6; 5.9] p = 0.45). The two groups did not differ significantly for the secondary outcomes. Conclusion Low-dose aspirin was not associated with a lower rate of either preeclampsia or birthweight ≤ 5th percentile in women identified by their first-trimester uterine artery Doppler as at high risk of preeclampsia. Trial registration (NCT0172946).

Published
2022

9. Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19

Author

Sterne, Jonathan A. C., Murthy, Srinivas, Diaz, Janet V., Slutsky, Arthur S., Villar, Jesús, Angus, Derek C., Annane, Djillali, Azevedo, Luciano Cesar Pontes, Berwanger, Otavio, Cavalcanti, Alexandre B., Dequin, Pierre-Francois, Du, Bin, Emberson, Jonathan, Fisher, David, Giraudeau, Bruno, Gordon, Anthony C., Granholm, Anders, Green, Cameron, Haynes, Richard, Heming, Nicholas, Higgins, Julian P. T., Horby, Peter, Jüni, Peter, Landray, Martin J., Le Gouge, Amelie, Leclerc, Marie, Lim, Wei Shen, Machado, Flávia R., McArthur, Colin, Meziani, Ferhat, Møller, Morten Hylander, Perner, Anders, Petersen, Marie Warrer, Savovic, Jelena, Tomazini, Bruno, Veiga, Viviane C., Webb, Steve, and Marshall, John C.

Subjects
General Medicine
Published
2020
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11. Corticosteroid therapy for critically ill patients with COVID-19:A structured summary of a study protocol for a prospective meta-analysis of randomized trials

Author

Sterne, Jonathan A C, Diaz, Janet, Villar, Jesús, Murthy, Srinivas, Slutsky, Arthur S, Perner, Anders, Jüni, Peter, Angus, Derek C, Annane, Djillali, Azevedo, Luciano Cesar Pontes, Du, Bin, Dequin, Pierre-Francois, Gordon, Anthony C, Green, Cameron, Higgins, Julian P T, Horby, Peter, Landray, Martin J, Lapadula, Giuseppe, Le Gouge, Amelie, Leclerc, Marie, Savović, Jelena, Tomazini, Bruno, Venkatesh, Balasubramanian, Webb, Steve, Marshall, John C, Sterne, Jonathan A C, Diaz, Janet, Villar, Jesús, Murthy, Srinivas, Slutsky, Arthur S, Perner, Anders, Jüni, Peter, Angus, Derek C, Annane, Djillali, Azevedo, Luciano Cesar Pontes, Du, Bin, Dequin, Pierre-Francois, Gordon, Anthony C, Green, Cameron, Higgins, Julian P T, Horby, Peter, Landray, Martin J, Lapadula, Giuseppe, Le Gouge, Amelie, Leclerc, Marie, Savović, Jelena, Tomazini, Bruno, Venkatesh, Balasubramanian, Webb, Steve, and Marshall, John C

Abstract

OBJECTIVES: Primary objective: To estimate the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization. Secondary objectives: To examine whether the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization varies between subgroups related to treatment characteristics, disease severity at the time of randomization, patient characteristics, or risk of bias. To examine the effect of corticosteroids compared with usual care or placebo on serious adverse events.STUDY DESIGN: Prospective meta-analysis of randomized controlled trials. Both placebo-controlled and open-label trials are eligible.PARTICIPANTS: Hospitalised, critically ill patients with suspected or confirmed COVID-19.INTERVENTION AND COMPARATOR: Intervention groups will have received therapeutic doses of a steroid (dexamethasone, hydrocortisone or methylprednisolone) with IV or oral administration immediately after randomization. The comparator groups will have received standard of care or usual care or placebo.MAIN OUTCOME: All-cause mortality up to 28 days after randomization.SEARCH METHODS: Systematic searching of clinicaltrials.gov , EudraCT, the WHO ISRCTN registry, and the Chinese clinical trials registry. Additionally, research and WHO networks will be asked for relevant trials.RISK OF BIAS ASSESSMENTS: These will be based on the Cochrane RoB 2 tool, and will use structured information provided by the trial investigators on a form designed for this prospective meta-analysis. We will use GRADE to assess the certainty of the evidence.STATISTICAL ANALYSES: Trial investigators will provide data on the numbers of participants who did and did not experience each outcome according to intervention group, overall and in specified subgroups. We will conduct fixed-effect (primary analysis) and random-effects (Paule-Mandel estimate of heterogeneity and Hartung

Published
2020

12. Association Between Administration of Systemic Corticosteroids and Mortality among Critically Ill Patients with COVID-19:A Meta-analysis

Author

Sterne, Jonathan A.C., Murthy, Srinivas, Diaz, Janet V., Slutsky, Arthur S., Villar, Jesús, Angus, Derek C., Annane, Djillali, Azevedo, Luciano Cesar Pontes, Berwanger, Otavio, Cavalcanti, Alexandre B., Dequin, Pierre Francois, Du, Bin, Emberson, Jonathan, Fisher, David, Giraudeau, Bruno, Gordon, Anthony C., Granholm, Anders, Green, Cameron, Haynes, Richard, Heming, Nicholas, Higgins, Julian P.T., Horby, Peter, Jüni, Peter, Landray, Martin J., Le Gouge, Amelie, Leclerc, Marie, Lim, Wei Shen, Machado, Flávia R., McArthur, Colin, Meziani, Ferhat, Møller, Morten Hylander, Perner, Anders, Petersen, Marie Warrer, Savović, Jelena, Tomazini, Bruno, Veiga, Viviane C., Webb, Steve, Marshall, John C., Sterne, Jonathan A.C., Murthy, Srinivas, Diaz, Janet V., Slutsky, Arthur S., Villar, Jesús, Angus, Derek C., Annane, Djillali, Azevedo, Luciano Cesar Pontes, Berwanger, Otavio, Cavalcanti, Alexandre B., Dequin, Pierre Francois, Du, Bin, Emberson, Jonathan, Fisher, David, Giraudeau, Bruno, Gordon, Anthony C., Granholm, Anders, Green, Cameron, Haynes, Richard, Heming, Nicholas, Higgins, Julian P.T., Horby, Peter, Jüni, Peter, Landray, Martin J., Le Gouge, Amelie, Leclerc, Marie, Lim, Wei Shen, Machado, Flávia R., McArthur, Colin, Meziani, Ferhat, Møller, Morten Hylander, Perner, Anders, Petersen, Marie Warrer, Savović, Jelena, Tomazini, Bruno, Veiga, Viviane C., Webb, Steve, and Marshall, John C.

Abstract

Importance: Effective therapies for patients with coronavirus disease 2019 (COVID-19) are needed, and clinical trial data have demonstrated that low-dose dexamethasone reduced mortality in hospitalized patients with COVID-19 who required respiratory support. Objective: To estimate the association between administration of corticosteroids compared with usual care or placebo and 28-day all-cause mortality. Design, Setting, and Participants: Prospective meta-analysis that pooled data from 7 randomized clinical trials that evaluated the efficacy of corticosteroids in 1703 critically ill patients with COVID-19. The trials were conducted in 12 countries from February 26, 2020, to June 9, 2020, and the date of final follow-up was July 6, 2020. Pooled data were aggregated from the individual trials, overall, and in predefined subgroups. Risk of bias was assessed using the Cochrane Risk of Bias Assessment Tool. Inconsistency among trial results was assessed using the I2statistic. The primary analysis was an inverse variance-weighted fixed-effect meta-analysis of overall mortality, with the association between the intervention and mortality quantified using odds ratios (ORs). Random-effects meta-analyses also were conducted (with the Paule-Mandel estimate of heterogeneity and the Hartung-Knapp adjustment) and an inverse variance-weighted fixed-effect analysis using risk ratios. Exposures: Patients had been randomized to receive systemic dexamethasone, hydrocortisone, or methylprednisolone (678 patients) or to receive usual care or placebo (1025 patients). Main Outcomes and Measures: The primary outcome measure was all-cause mortality at 28 days after randomization. A secondary outcome was investigator-defined serious adverse events. Results: A total of 1703 patients (median age, 60 years [interquartile range, 52-68 years]; 488 [29%] women) were included in the analysis. Risk of bias was assessed as "low" for 6 of the 7 mortality results and as "some concerns" in

Published
2020

14. Effect of Not Monitoring Residual Gastric Volume on Risk of Ventilator-Associated Pneumonia in Adults Receiving Mechanical Ventilation and Early Enteral Feeding

Author

Reignier, Jean, primary, Mercier, Emmanuelle, additional, Le Gouge, Amelie, additional, Boulain, Thierry, additional, Desachy, Arnaud, additional, Bellec, Frederic, additional, Clavel, Marc, additional, Frat, Jean-Pierre, additional, Plantefeve, Gaetan, additional, Quenot, Jean-Pierre, additional, and Lascarrou, Jean-Baptiste, additional

Published
2014
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15. Corticosteroid therapy for critically ill patients with COVID-19: A structured summary of a study protocol for a prospective meta-analysis of randomized trials.

Author

Sterne, Jonathan A. C., Diaz, Janet, Villar, Jesús, Murthy, Srinivas, Slutsky, Arthur S., Perner, Anders, Jüni, Peter, Angus, Derek C., Annane, Djillali, Azevedo, Luciano Cesar Pontes, Du, Bin, Dequin, Pierre-Francois, Gordon, Anthony C., Green, Cameron, Higgins, Julian P. T., Horby, Peter, Landray, Martin J., Lapadula, Giuseppe, Le Gouge, Amelie, and Leclerc, Marie

Subjects
COVID-19, META-analysis, ODDS ratio, CRITICALLY ill, CLINICAL trial registries, LONGITUDINAL method, CRITICALLY ill children, RANDOMIZED controlled trials
Abstract

Objectives: Primary objective: To estimate the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization. Secondary objectives: To examine whether the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization varies between subgroups related to treatment characteristics, disease severity at the time of randomization, patient characteristics, or risk of bias. To examine the effect of corticosteroids compared with usual care or placebo on serious adverse events.Study Design: Prospective meta-analysis of randomized controlled trials. Both placebo-controlled and open-label trials are eligible.Participants: Hospitalised, critically ill patients with suspected or confirmed COVID-19.Intervention and Comparator: Intervention groups will have received therapeutic doses of a steroid (dexamethasone, hydrocortisone or methylprednisolone) with IV or oral administration immediately after randomization. The comparator groups will have received standard of care or usual care or placebo.Main Outcome: All-cause mortality up to 28 days after randomization.Search Methods: Systematic searching of clinicaltrials.gov , EudraCT, the WHO ISRCTN registry, and the Chinese clinical trials registry. Additionally, research and WHO networks will be asked for relevant trials.Risk Of Bias Assessments: These will be based on the Cochrane RoB 2 tool, and will use structured information provided by the trial investigators on a form designed for this prospective meta-analysis. We will use GRADE to assess the certainty of the evidence.Statistical Analyses: Trial investigators will provide data on the numbers of participants who did and did not experience each outcome according to intervention group, overall and in specified subgroups. We will conduct fixed-effect (primary analysis) and random-effects (Paule-Mandel estimate of heterogeneity and Hartung-Knapp adjustment) meta-analyses. We will quantify inconsistency in effects between trials using I2 statistics. Evidence for subgroup effects will be quantified by ratios of odds ratios comparing effects in the subgroups, and corresponding interaction p-values. Comparisons between subgroups defined by trial characteristics will be made using random-effects meta-regression. Comparisons between subgroups defined by patient characteristics will be made by estimating trial-specific ratios of odds ratios comparing intervention effects between subgroups then combining these using random-effects meta-analysis. Steroid interventions will be classified as high or low dose according to whether the dose is greater or less than or equal to 400 mg hydrocortisone per day or equivalent. We will use network meta-analysis methods to make comparisons between the effects of high and low dose steroid interventions (because one trial randomized participants to both low and high dose steroid arms).Prospero Registration Number: CRD42020197242 FULL PROTOCOL: The full protocol for this prospective meta-analysis is attached as an additional file, accessible from the Trials website (Additional file 1). To expedite dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol for the systematic review. [ABSTRACT FROM AUTHOR]

Published
2020
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16. Corticosteroid therapy for critically ill patients with COVID-19: A structured summary of a study protocol for a prospective meta-analysis of randomized trials

Author

Sterne, Jonathan A C, Diaz, Janet, Villar, Jesús, Murthy, Srinivas, Slutsky, Arthur S, Perner, Anders, Jüni, Peter, Angus, Derek C, Annane, Djillali, Azevedo, Luciano C P, Du, Bin, Dequin, Pierre-Francois, Gordon, Anthony C, Green, Cameron, Higgins, Julian P T, Horby, Peter, Landray, Martin J, Lapadula, Giuseppe, Le Gouge, Amelie, Leclerc, Marie, Savović, Jelena, Tomazini, Bruno, Venkatesh, Balasubramanian, Webb, Steve, and Marshall, John C

Subjects
3. Good health
Abstract

Objectives: Primary objective: To estimate the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization. Secondary objectives: To examine whether the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization varies between subgroups related to treatment characteristics, disease severity at the time of randomization, patient characteristics, or risk of bias. To examine the effect of corticosteroids compared with usual care or placebo on serious adverse events. Study design: Prospective meta-analysis of randomized controlled trials. Both placebo-controlled and open-label trials are eligible. Participants: Hospitalised, critically ill patients with suspected or confirmed COVID-19. Intervention and comparator: Intervention groups will have received therapeutic doses of a steroid (dexamethasone, hydrocortisone or methylprednisolone) with IV or oral administration immediately after randomization. The comparator groups will have received standard of care or usual care or placebo. Main outcome: All-cause mortality up to 28 days after randomization. Search methods: Systematic searching of clinicaltrials.gov, EudraCT, the WHO ISRCTN registry, and the Chinese clinical trials registry. Additionally, research and WHO networks will be asked for relevant trials. Risk of bias assessments: These will be based on the Cochrane RoB 2 tool, and will use structured information provided by the trial investigators on a form designed for this prospective meta-analysis. Summary of findings: We will use GRADE to assess the certainty of the evidence. Statistical analyses: Trial investigators will provide data on the numbers of participants who did and did not experience each outcome according to intervention group, overall and in specified subgroups. We will conduct fixed-effect (primary analysis) and random-effects (Paule-Mandel estimate of heterogeneity and Hartung-Knapp adjustment) meta-analyses. We will quantify inconsistency in effects between trials using I2 statistics. Evidence for subgroup effects will be quantified by ratios of odds ratios comparing effects in the subgroups, and corresponding interaction p-values. Comparisons between subgroups defined by trial characteristics will be made using random-effects meta-regression. Comparisons between subgroups defined by patient characteristics will be made by estimating trial-specific ratios of odds ratios comparing intervention effects between subgroups then combining these using random-effects meta-analysis. Steroid interventions will be classified as high or low dose according to whether the dose is greater or less than or equal to 400 mg hydrocortisone per day or equivalent. We will use network meta-analysis methods to make comparisons between the effects of high and low dose steroid interventions (because one trial randomized participants to both low and high dose steroid arms). PROSPERO registration number CRD42020197242 Full protocol: The full protocol for this prospective meta-analysis is attached as an additional file, accessible from the Trials website (Additional file 1). To expedite dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol for the systematic review.

18. Low-dose aspirin to prevent preeclampsia and growth restriction in nulliparous women identified by uterine artery Doppler as at high risk of preeclampsia: A double blinded randomized placebo-controlled trial.

Author

Diguisto C, Le Gouge A, Marchand MS, Megier P, Ville Y, Haddad G, Winer N, Arthuis C, Doret M, Debarge VH, Flandrin A, Delmas HL, Gallot D, Mares P, Vayssiere C, Sentilhes L, Cheve MT, Paumier A, Durin L, Schaub B, Equy V, Giraudeau B, and Perrotin F

Subjects
Infant, Newborn, Female, Pregnancy, Humans, Birth Weight, Aspirin therapeutic use, Pregnancy Trimester, First, Uterine Artery diagnostic imaging, Pre-Eclampsia prevention & control, Pre-Eclampsia drug therapy
Abstract

Introduction: This trial evaluates whether daily low-dose aspirin initiated before 16 weeks of gestation can reduce preeclampsia and fetal growth restriction in nulliparous women identified by first-trimester uterine artery Dopplers as at high risk of preeclampsia., Methods: This randomized, blinded, placebo-controlled, parallel-group trial took place in 17 French obstetric departments providing antenatal care. Pregnant nulliparous women aged ≥ 18 years with a singleton pregnancy at a gestational age < 16 weeks of gestation with a lowest pulsatility index ≥ 1.7 or a bilateral protodiastolic notching for both uterine arteries on an ultrasound performed between 11+0 and 13+6 weeks by a certified sonographer were randomized at a 1:1 ratio to 160 mg of low-dose aspirin or to placebo to be taken daily from inclusion to their 34th week of gestation. The main outcome was preeclampsia or a birthweight ≤ 5th percentile. Other outcomes included preeclampsia, severe preeclampsia, preterm preeclampsia, preterm delivery before 34 weeks, mode of delivery, type of anesthesia, birthweight ≤ 5th percentile and perinatal death., Results: The trial was interrupted due to recruiting difficulties. Between June 2012 and June 2016, 1104 women were randomized, two withdrew consent, and two had terminations of pregnancies. Preeclampsia or a birthweight ≤ 5th percentile occurred in 88 (16.0%) women in the low-dose aspirin group and in 79 (14.4%) in the placebo group (proportion difference 1.6 [-2.6; 5.9] p = 0.45). The two groups did not differ significantly for the secondary outcomes., Conclusion: Low-dose aspirin was not associated with a lower rate of either preeclampsia or birthweight ≤ 5th percentile in women identified by their first-trimester uterine artery Doppler as at high risk of preeclampsia., Trial Registration: (NCT0172946)., Competing Interests: The authors have declared that no competing interests exist.

Published
2022
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