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Intensive Care Med. 2019 Mar 12. doi: 10.1007/s00134-019-05589-y. [Epub ahead of print]

Pantoprazole prophylaxis in ICU patients with high severity of disease: a post hoc analysis of the placebo-controlled SUP-ICU trial.

Author information

1
Department of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. soeren.marker@regionh.dk.
2
Centre for Research in Intensive Care (CRIC), Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. soeren.marker@regionh.dk.
3
Department of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
4
Centre for Research in Intensive Care (CRIC), Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
5
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
6
Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
7
Center for Statistical Science, Peking University, Beijing, China.
8
Department of Adult Critical Care, University Hospital of Wales, Cardiff, UK.
9
Pharmacy Department, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
10
Department of Intensive Care Medicine, Kuopio University Hospital, Kuopio, Finland.
11
Department of Critical Care, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
12
Department of Anaesthesia and Intensive Care, Haukeland University Hospital, Bergen, Norway.
13
Department of Clinical Medicine, UiB, Bergen, Norway.
14
Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

Abstract

PURPOSE:

In the subgroup of patients with Simplified Acute Physiology Score (SAPS) II > 53 in the Stress Ulcer Prophylaxis in Intensive Care Unit (SUP-ICU) trial, there was interaction (P = 0.049) suggesting increased mortality in patients allocated to pantoprazole as compared with placebo. We aimed to explore this further.

METHODS:

The SUP-ICU trial allocated acutely admitted adults at risk of gastrointestinal bleeding to pantoprazole vs placebo. In this post hoc study, we repeated all the preplanned analyses of SUP-ICU in patients with baseline SAPS II > 53.

RESULTS:

A total of 1140 patients had a complete SAPS II > 53 and were included. At 90 days, 272/579 patients (47%) assigned to pantoprazole had died, as compared with 229/558 patients (41%) assigned to placebo [relative risk 1.13; 95% confidence interval (CI) 1.00-1.29]. This was supported by sensitivity analyses adjusted for risk factors and those in the per-protocol population. When accounting for patients with incomplete SAPS II in two additional analyses, the relative risk was 1.08; 95% CI 0.96-1.22 and 1.10; 95% CI 0.97-1.25. This was also observed for the secondary outcome days alive without life support. There were no differences between the intervention groups in the other secondary outcomes.

CONCLUSIONS:

In this post hoc analysis of patients with high disease severity included in the SUP-ICU trial, we observed higher 90-day mortality and fewer days alive without life support with pantoprazole vs placebo. Some of this may have been explained by missing SAPS II data, but further research is needed to draw firm conclusions. CLINICALTRIALS.GOV: ClinicalTrials.gov No. NCT02467621.

KEYWORDS:

All-cause mortality; Gastrointestinal bleeding; Intensive care unit; Stress ulcer prophylaxis; Stress ulceration

PMID:
30863936
DOI:
10.1007/s00134-019-05589-y

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