Pantoprazole in ICU patients at risk for gastrointestinal bleeding-1-year mortality in the SUP-ICU trial.

Marker, Søren; Krag, Mette; Perner, Anders; Wetterslev, Jørn; Lange, Theis; Wise, Matt P; Borthwick, Mark; Bendel, Stepani; Keus, Frederik; Guttormsen, Anne Berit; Schefold, Jörg Christian; Rasmussen, Bodil S; Elkmann, Thomas; Bestle, Morten; Arenkiel, Bjørn; Laake, Jon H; Kamper, Maj K; Lång, Maarit; Pawlowicz-Dworzanska, Malgorzata B; Karlsson, Sari; ... (2019). Pantoprazole in ICU patients at risk for gastrointestinal bleeding-1-year mortality in the SUP-ICU trial. Acta anaesthesiologica Scandinavica, 63(9), pp. 1184-1190. Wiley-Blackwell 10.1111/aas.13436

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BACKGROUND The long-term effects of stress ulcer prophylaxis with pantoprazole are unknown in ICU patients. We report 1-year mortality outcome in the Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial. METHODS In the SUP-ICU trial, acutely admitted adult ICU patients at risk of gastrointestinal bleeding were randomised to intravenous pantoprazole 40 mg vs placebo (saline) once daily during their ICU stay. We assessed mortality at 1 year and did sensitivity analyses according to the trial protocol and statistical analysis plan. RESULTS A total of 3261 of the 3291 patients with available data (99.1%) were followed up at 1 year after randomisation; 1635 were allocated to pantoprazole and 1626 to placebo. At 1 year after randomisation, 610 of 1635 patients (37.3%) had died in the pantoprazole group as compared with 601 of 1626 (37.0%) in the placebo group (relative risk, 1.01; 95% confidence interval 0.92-1.10). The results were consistent in the sensitivity analysis adjusted for baseline risk factors and in those of the per-protocol population. We did not observe heterogeneity in the effect of pantoprazole vs placebo on 1-year mortality in the predefined subgroups, that is, patients with and without shock, mechanical ventilation, liver disease, coagulopathy, high disease severity (SAPS II > 53) or in medical vs surgical ICU patients. CONCLUSION We did not observe a difference in 1-year mortality among acutely admitted adult ICU patients with risk factors for gastrointestinal bleeding allocated to stress ulcer prophylaxis with pantoprazole or placebo during the ICU stay. (The SUP-ICU trial was funded by Innovation Fund Denmark and others; ClinicalTrials.gov number, NCT02467621).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic of Intensive Care

UniBE Contributor:

Schefold, Jörg Christian

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0001-5172

Publisher:

Wiley-Blackwell

Language:

English

Submitter:

Mirella Aeberhard

Date Deposited:

22 Aug 2019 10:30

Last Modified:

25 Oct 2019 02:52

Publisher DOI:

10.1111/aas.13436

PubMed ID:

31282567

Uncontrolled Keywords:

all-cause mortality gastrointestinal bleeding intensive care unit long-term follow-up stress ulcer prophylaxis stress ulceration

BORIS DOI:

10.7892/boris.132119

URI:

https://boris.unibe.ch/id/eprint/132119

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