1. Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU
- Author
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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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