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1. Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock

Author

Kjær, Maj-Brit Nørregaard, Meyhoff, Tine Sylvest, Sivapalan, Praleene, Granholm, Anders, Hjortrup, Peter Buhl, Madsen, Martin Bruun, Møller, Morten Hylander, Egerod, Ingrid, Wetterslev, Jørn, Lange, Theis, Cronhjort, Maria, Laake, Jon Henrik, Jakob, Stephan M., Nalos, Marek, Ostermann, Marlies, Gould, Doug, Cecconi, Maurizio, Malbrain, Manu L. N. G., Ahlstedt, Christian, Kiel, Louise Bendix, Bestle, Morten H., Nebrich, Lars, Hildebrandt, Thomas, Russell, Lene, Vang, Marianne, Rasmussen, Michael Lindhart, Sølling, Christoffer, Brøchner, Anne Craveiro, Krag, Mette, Pfortmueller, Carmen, Kriz, Miroslav, Siegemund, Martin, Albano, Giovanni, Aagaard, Søren Rosborg, Bundgaard, Helle, Crone, Vera, Wichmann, Sine, Johnstad, Bror, Martin, Yvonne Karin, Seidel, Philipp, Mårtensson, Johan, Hollenberg, Jacob, Wistrand, Mats, Donati, Abele, Barbara, Enrico, Karvunidis, Thomas, Hollinger, Alexa, Carsetti, Andrea, Lumlertgul, Nuttha, Joelsson-Alm, Eva, Lambiris, Nikolas, Aslam, Tayyba Naz, Friberg, Fredrik Femtehjell, Vesterlund, Gitte Kingo, Mortensen, Camilla Bekker, Vestergaard, Stine Rom, Caspersen, Sidsel Fjordbak, Jensen, Diana Bertelsen, Borup, Morten, Rasmussen, Bodil Steen, and Perner, Anders

Published
2023
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2. Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock

Author

Kjær, Maj Brit Nørregaard, Meyhoff, Tine Sylvest, Sivapalan, Praleene, Granholm, Anders, Hjortrup, Peter Buhl, Madsen, Martin Bruun, Møller, Morten Hylander, Egerod, Ingrid, Wetterslev, Jørn, Lange, Theis, Cronhjort, Maria, Laake, Jon Henrik, Jakob, Stephan M., Nalos, Marek, Ostermann, Marlies, Gould, Doug, Cecconi, Maurizio, Malbrain, Manu L.N.G., Ahlstedt, Christian, Kiel, Louise Bendix, Bestle, Morten H., Nebrich, Lars, Hildebrandt, Thomas, Russell, Lene, Vang, Marianne, Rasmussen, Michael Lindhart, Sølling, Christoffer, Brøchner, Anne Craveiro, Krag, Mette, Pfortmueller, Carmen, Kriz, Miroslav, Siegemund, Martin, Albano, Giovanni, Aagaard, Søren Rosborg, Bundgaard, Helle, Crone, Vera, Wichmann, Sine, Johnstad, Bror, Martin, Yvonne Karin, Seidel, Philipp, Mårtensson, Johan, Hollenberg, Jacob, Wistrand, Mats, Donati, Abele, Barbara, Enrico, Karvunidis, Thomas, Hollinger, Alexa, Carsetti, Andrea, Lumlertgul, Nuttha, Joelsson-Alm, Eva, Lambiris, Nikolas, Aslam, Tayyba Naz, Friberg, Fredrik Femtehjell, Vesterlund, Gitte Kingo, Mortensen, Camilla Bekker, Vestergaard, Stine Rom, Caspersen, Sidsel Fjordbak, Jensen, Diana Bertelsen, Borup, Morten, Rasmussen, Bodil Steen, Perner, Anders, Kjær, Maj Brit Nørregaard, Meyhoff, Tine Sylvest, Sivapalan, Praleene, Granholm, Anders, Hjortrup, Peter Buhl, Madsen, Martin Bruun, Møller, Morten Hylander, Egerod, Ingrid, Wetterslev, Jørn, Lange, Theis, Cronhjort, Maria, Laake, Jon Henrik, Jakob, Stephan M., Nalos, Marek, Ostermann, Marlies, Gould, Doug, Cecconi, Maurizio, Malbrain, Manu L.N.G., Ahlstedt, Christian, Kiel, Louise Bendix, Bestle, Morten H., Nebrich, Lars, Hildebrandt, Thomas, Russell, Lene, Vang, Marianne, Rasmussen, Michael Lindhart, Sølling, Christoffer, Brøchner, Anne Craveiro, Krag, Mette, Pfortmueller, Carmen, Kriz, Miroslav, Siegemund, Martin, Albano, Giovanni, Aagaard, Søren Rosborg, Bundgaard, Helle, Crone, Vera, Wichmann, Sine, Johnstad, Bror, Martin, Yvonne Karin, Seidel, Philipp, Mårtensson, Johan, Hollenberg, Jacob, Wistrand, Mats, Donati, Abele, Barbara, Enrico, Karvunidis, Thomas, Hollinger, Alexa, Carsetti, Andrea, Lumlertgul, Nuttha, Joelsson-Alm, Eva, Lambiris, Nikolas, Aslam, Tayyba Naz, Friberg, Fredrik Femtehjell, Vesterlund, Gitte Kingo, Mortensen, Camilla Bekker, Vestergaard, Stine Rom, Caspersen, Sidsel Fjordbak, Jensen, Diana Bertelsen, Borup, Morten, Rasmussen, Bodil Steen, and Perner, Anders

Abstract

Purpose: To assess long-term outcomes of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock included in the European Conservative versus Liberal Approach to Fluid Therapy in Septic Shock in Intensive Care (CLASSIC) trial. Methods: We conducted the pre-planned analyses of mortality, health-related quality of life (HRQoL) using EuroQol (EQ)-5D-5L index values and EQ visual analogue scale (VAS), and cognitive function using Mini Montreal Cognitive Assessment (Mini MoCA) test at 1 year. Deceased patients were assigned numerical zero for HRQoL as a state equal to death and zero for cognitive function outcomes as worst possible score, and we used multiple imputation for missing data on HRQoL and cognitive function. Results: Among 1554 randomized patients, we obtained 1-year data on mortality in 97.9% of patients, HRQoL in 91.3%, and cognitive function in 86.3%. One-year mortality was 385/746 (51.3%) in the restrictive-fluid group versus 383/767 (49.9%) in the standard-fluid group, absolute risk difference 1.5%-points [99% confidence interval (CI) − 4.8 to 7.8]. Mean differences were 0.00 (99% CI − 0.06 to 0.05) for EQ-5D-5L index values, − 0.65 for EQ VAS (− 5.40 to 4.08), and − 0.14 for Mini MoCA (− 1.59 to 1.14) for the restrictive-fluid group versus the standard-fluid group. The results for survivors only were similar in both groups. Conclusions: Among adult ICU patients with septic shock, restrictive versus standard IV fluid therapy resulted in similar survival, HRQoL, and cognitive function at 1 year, but clinically important differences could not be ruled out.

Published
2023

3. Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock

Author

Kjær, Maj-Brit Nørregaard, primary, Meyhoff, Tine Sylvest, additional, Sivapalan, Praleene, additional, Granholm, Anders, additional, Hjortrup, Peter Buhl, additional, Madsen, Martin Bruun, additional, Møller, Morten Hylander, additional, Egerod, Ingrid, additional, Wetterslev, Jørn, additional, Lange, Theis, additional, Cronhjort, Maria, additional, Laake, Jon Henrik, additional, Jakob, Stephan M., additional, Nalos, Marek, additional, Ostermann, Marlies, additional, Gould, Doug, additional, Cecconi, Maurizio, additional, Malbrain, Manu L. N. G., additional, Ahlstedt, Christian, additional, Kiel, Louise Bendix, additional, Bestle, Morten H, additional, Nebrich, Lars, additional, Hildebrandt, Thomas, additional, Russell, Lene, additional, Vang, Marianne, additional, Lindhart, Michael, additional, Søllling, Christoffer, additional, Brøchner, Anne Craveiro, additional, Krag, Mette, additional, Pfortmueller, Carmen, additional, Kriz, Miroslav, additional, Siegemund, Martin, additional, Albano, Giovanni, additional, Aagaard, Søren Rosborg, additional, Bundgaard, Helle, additional, Crone, Vera, additional, Wichmann, Sine, additional, Johnstad, Bror, additional, Martin, Yvonne Karin, additional, Seidel, Philipp, additional, Mårtensson, Johan, additional, Hollenberg, Jacob, additional, Witstrand, Mats, additional, Donati, Abele, additional, Barbara, Enrico, additional, Karvunidis, Thomas, additional, Hollinger, Alexa, additional, Carsetti, Andrea, additional, Lumlertgul, Nuttha, additional, Joelsson-Alm, Eva, additional, Lambiris, Nikolas, additional, Aslam, Tayyba Naz, additional, Friberg, Fredrik Femtehjell, additional, Vesterlund, Gitte Kingo, additional, Mortensen, Camilla Bekker, additional, Vestergaard, Stine Rom, additional, Caspersen, Sidsel Fjordbak, additional, Jensen, Diana Bertelsen, additional, Brorup, Morten, additional, Rasmussen, Bodil Steen, additional, and Perner, Anders, additional

Published
2023
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5. Handling oxygenation targets in ICU patients with COVID-19-Protocol and statistical analysis plan in the HOT-COVID trial.

Author

Mølgaard Nielsen, Frederik, Lass Klitgaard, Thomas, Crescioli, Elena, Rosborg Aagaard, Søren, Andreasen, Anne Sofie, Musaeus Poulsen, Lone, Siegemund, Martin, Craveiro Brøchner, Anne, Bestle, Morten H., Andi Iversen, Susanne, Brand, Björn A., Laake, Jon Henrik, Grøfte, Thorbjørn, Hildebrandt, Thomas, Lange, Theis, Perner, Anders, Lilleholt Schjørring, Olav, Steen Rasmussen, Bodil, Klitgaard, Thomas Lass, and Aagaard, Søren Rosborg

Subjects
COVID-19, OXYGEN in the blood, INTENSIVE care units, RENAL replacement therapy, STATISTICS
Abstract

Background: Coronavirus disease (COVID-19) primarily affects the lungs and lower airways and may present as hypoxaemic respiratory failure requiring admission to an intensive care unit (ICU) for supportive treatment. Here, supplemental oxygen remains essential for COVID-19 patient management, but the optimal dosage is not defined. We hypothesize that targeting an arterial partial pressure of oxygen of 8 kPa throughout ICU admission is superior to targeting 12 kPa.Methods: The Handling Oxygenation Targets in ICU patients with COVID-19 (HOT-COVID) trial, is an investigator-initiated, pragmatic, multicentre, randomized, parallel-group trial comparing a lower oxygenation target versus a higher oxygenation target in adult ICU patients with COVID-19. The primary outcome is days alive without life-support (use of mechanical ventilation, renal replacement therapy or vasoactive therapy) at day 90. Secondary outcomes are 90-day and 1-year mortality, serious adverse events in the ICU and days alive and out of hospital in the 90-day period, health-related quality-of-life at 1 year, and health economic analyses. One-year follow-up of cognitive and pulmonary function is planned in a subgroup of Danish patients. We will include 780 patients to detect or reject an absolute increase in days alive without life-support of 7 days with an α of 5% and a β of 20%. An interim analysis is planned after 90-day follow-up of 390 patients.Conclusions: The HOT-COVID trial will provide patient-important data on the effect of two oxygenation targets in ICU patients with COVID-19 and hypoxia. This protocol paper describes the background, design and statistical analysis plan for the trial. [ABSTRACT FROM AUTHOR]

Published
2021
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6. Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU

Author

Krag, Mette, Marker, Søren, Perner, Anders, Wetterslev, Jørn, Wise, Matt P, Schefold, Joerg C, Keus, Frederik, Guttormsen, Anne B, Bendel, Stepani, Borthwick, Mark, Lange, Theis, Rasmussen, Bodil S, Siegemund, Martin, Bundgaard, Helle, Elkmann, Thomas, Jensen, Jacob V, Nielsen, Rune D, Liboriussen, Lisbeth, Bestle, Morten H, Elkjær, Jeanie M, Palmqvist, Dorte F, Bäcklund, Minna, Laake, Jon H, Bådstøløkken, Per M, Grönlund, Juha, Breum, Olena, Walli, Akil, Winding, Robert, Iversen, Susanne, Jarnvig, Inge-Lise, White, Jonathan O, Brand, Björn, Madsen, Martin B, Quist, Lars, Thornberg, Klaus J, Møller, Anders, Wiis, Jørgen, Granholm, Anders, Anthon, Carl T, Meyhoff, Tine S, Hjortrup, Peter B, Aagaard, Søren R, Andreasen, Jo B, Sørensen, Christina A, Haure, Pernille, Hauge, Jacob, Hollinger, Alexa, Scheuzger, Jonas, Tuchscherer, Daniel, Vuilliomenet, T, Takala, J, Jakob, S. M., Vang, M. L., Pælestik, K. B., Andersen, K. L. D., van der Horst, I. C. C., Dieperink, W., Fjølner, J., Kjer, C. K. W., Sølling, C, Sølling, C. G., Karttunen, J., Morgan, M. P. G., Sjøbø, B., Engstrøm, J., Agerholm-Larsen, B, Møller, Morten H, Rasmussen, Bodil Steen, Aagaard, Søren Rosborg, Bønding Andreasen, Jo, Ankjær Sørensen, Christina, Christensen, Pernille Haure, Levin, Marianne, Klemmesen Jensen, Käte, Lundberg, Lillian Skov Søndergaard, Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), Cardiovascular Centre (CVC), and Critical Care

Subjects
Pantoprazole/adverse effects, Male, INTENSIVE-CARE-UNIT, intraveneuze injecties, law.invention, Proton Pump Inhibitors/adverse effects, intensive care afdelingen, 0302 clinical medicine, Randomized controlled trial, law, overlevingsanalyse, Risk Factors, adults, Medicine, maagzweren, Artikkel, Single-Blind Method, 030212 general & internal medicine, 610 Medicine & health, Pantoprazole, enkele blindering, volwassenen, General Medicine, Middle Aged, Intensive care unit, Intensive Care Units, Injections, Intravenous, STRESS-ULCER PROPHYLAXIS, Female, psychosocial stress, Gastrointestinal Hemorrhage, kritieke ziekte, medicine.drug, medicine.medical_specialty, Gastrointestinal bleeding, risicofactoren, Peptic Ulcer, Randomization, bijwerkingen, Gastrointestinal Hemorrhage/epidemiology, Critical Illness, Placebo, Peptic Ulcer/prevention & control, psychosociale stress, PROTON-PUMP INHIBITORS, 03 medical and health sciences, Medisinske Fag: 700 [VDP], Stress, Physiological, Internal medicine, SCORE, Humans, VDP::Medisinske Fag: 700, Aged, gastro-intestinale bloeding, SEPSIS, business.industry, intravenous injections, 030208 emergency & critical care medicine, Proton Pump Inhibitors, pantaprazole, ta3121, medicine.disease, Survival Analysis, Confidence interval, Critical Illness/mortality, Relative risk, adverse effects, business, single-blind methoden, protonpompremmers
Abstract

Background\ud\udProphylaxis for gastrointestinal stress ulceration is frequently given to patients in the intensive care unit (ICU), but its risks and benefits are unclear.\udMethods\ud\udIn this European, multicenter, parallel-group, blinded trial, we randomly assigned adults who had been admitted to the ICU for an acute condition (i.e., an unplanned admission) and who were at risk for gastrointestinal bleeding to receive 40 mg of intravenous pantoprazole (a proton-pump inhibitor) or placebo daily during the ICU stay. The primary outcome was death by 90 days after randomization.\udResults\ud\udA total of 3298 patients were enrolled; 1645 were randomly assigned to the pantoprazole group and 1653 to the placebo group. Data on the primary outcome were available for 3282 patients (99.5%). At 90 days, 510 patients (31.1%) in the pantoprazole group and 499 (30.4%) in the placebo group had died (relative risk, 1.02; 95% confidence interval [CI], 0.91 to 1.13; P=0.76). During the ICU stay, at least one clinically important event (a composite of clinically important gastrointestinal bleeding, pneumonia, Clostridium difficile infection, or myocardial ischemia) had occurred in 21.9% of patients assigned to pantoprazole and 22.6% of those assigned to placebo (relative risk, 0.96; 95% CI, 0.83 to 1.11). In the pantoprazole group, 2.5% of patients had clinically important gastrointestinal bleeding, as compared with 4.2% in the placebo group. The number of patients with infections or serious adverse reactions and the percentage of days alive without life support within 90 days were similar in the two groups.\udConclusions\ud\udAmong adult patients in the ICU who were at risk for gastrointestinal bleeding, mortality at 90 days and the number of clinically important events were similar in those assigned to pantoprazole and those assigned to placebo. (Funded by Innovation Fund Denmark and others; SUP-ICU ClinicalTrials.gov number, NCT02467621. opens in new tab.)

Published
2018
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7. Sevoflurane improves myocardial ischaemic tolerance in a closed-chest porcine model

Author

Larsen, Jens Kjærgaard Rolighed, Aagaard, Søren Rosborg, Lie, Rasmus Haarup, Sloth, Erik, and Hasenkam, John Michael

Abstract

Udgivelsesdato: 2008-Nov Aims: Volatile anaesthetics prevent experimental myocardial ischaemia-reperfusion injury (I/R) in several species, but this finding is partially inconsistent with clinical evidence. Some experimental models may not accurately represent the complex signal transduction pathways triggered by volatile anaesthetics. We therefore investigated sevoflurane I/R prevention in vivo in a porcine model with greater likeness to human physiology than models previously used and compared it with neutral anaesthetic. Methods and results: Myocardial infarct size [IS/AAR] was compared in three groups of pigs (N=35) randomised to Control anaesthesia (pentobarbital infusion, n=12), sevoflurane inhalation alone (end-tidal concentration 3.2%) (Sevo, n=9), or both Combined (n=14), throughout ischaemia and reperfusion. Anterior/septal myocardial infarcts resulted from distal LAD coronary artery occlusion by balloon catheter for 45 min followed by 120 min of reperfusion. [IS/AAR] was measured in tetrazolium-stained heart slices after standardised image processing with computer-assisted planimetry. Measurements included full invasive monitoring. Control animals developed infarction in 55.0+/-3.9% (SEM) of the area at risk, Sevo in 17.5+/-4.4% (P=0.0002), and Combined with pentobarbital in 24.3+/-3.8% (P=0.0001) of the AAR, sevoflurane reducing infarct size significantly (68% and 60%, respectively). Conclusions: Sevoflurane markedly decreased myocardial infarct size after prolonged coronary occlusion in a porcine model. In addition to novel sevoflurane cardioprotection in the closed-chest model, which is more comparable to normal human hearts than models previously used, sevoflurane cardioprotection is substantiated in the juvenile intact organism. The perspectives underline recommending volatile anaesthetics in risk patients and in cardiac surgery.

Published
2008
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