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Randomized Controlled Trial
. 2018 Dec 6;379(23):2199-2208.
doi: 10.1056/NEJMoa1714919. Epub 2018 Oct 24.

Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU

Mette Krag  1 Søren Marker  1 Anders Perner  1 Jørn Wetterslev  1 Matt P Wise  1 Joerg C Schefold  1 Frederik Keus  1 Anne B Guttormsen  1 Stepani Bendel  1 Mark Borthwick  1 Theis Lange  1 Bodil S Rasmussen  1 Martin Siegemund  1 Helle Bundgaard  1 Thomas Elkmann  1 Jacob V Jensen  1 Rune D Nielsen  1 Lisbeth Liboriussen  1 Morten H Bestle  1 Jeanie M Elkjær  1 Dorte F Palmqvist  1 Minna Bäcklund  1 Jon H Laake  1 Per M Bådstøløkken  1 Juha Grönlund  1 Olena Breum  1 Akil Walli  1 Robert Winding  1 Susanne Iversen  1 Inge-Lise Jarnvig  1 Jonathan O White  1 Björn Brand  1 Martin B Madsen  1 Lars Quist  1 Klaus J Thornberg  1 Anders Møller  1 Jørgen Wiis  1 Anders Granholm  1 Carl T Anthon  1 Tine S Meyhoff  1 Peter B Hjortrup  1 Søren R Aagaard  1 Jo B Andreasen  1 Christina A Sørensen  1 Pernille Haure  1 Jacob Hauge  1 Alexa Hollinger  1 Jonas Scheuzger  1 Daniel Tuchscherer  1 Thierry Vuilliomenet  1 Jukka Takala  1 Stephan M Jakob  1 Marianne L Vang  1 Kim B Pælestik  1 Karen L D Andersen  1 Iwan C C van der Horst  1 Willem Dieperink  1 Jesper Fjølner  1 Cilia K W Kjer  1 Christine Sølling  1 Christoffer G Sølling  1 Johanna Karttunen  1 Matt P G Morgan  1 Brit Sjøbø  1 Janus Engstrøm  1 Birgit Agerholm-Larsen  1 Morten H Møller  1 SUP-ICU trial group
Collaborators, Affiliations
Randomized Controlled Trial

Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU

Mette Krag et al. N Engl J Med. .

Abstract

Background: Prophylaxis for gastrointestinal stress ulceration is frequently given to patients in the intensive care unit (ICU), but its risks and benefits are unclear.

Methods: In 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.

Results: A 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.

Conclusions: Among 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 .).

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