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

Marker, Søren; Perner, Anders; Wetterslev, Jørn; Krag, Mette; Lange, Theis; Wise, Matt P; Borthwick, Mark; Bendel, Stepani; Keus, Frederik; Guttormsen, Anne Berit; Schefold, Jörg Christian; Møller, Morten Hylander (2019). Pantoprazole prophylaxis in ICU patients with high severity of disease: a post hoc analysis of the placebo-controlled SUP-ICU trial. Intensive care medicine, 45(5), pp. 609-618. Springer-Verlag 10.1007/s00134-019-05589-y

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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.

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:

0342-4642

Publisher:

Springer-Verlag

Language:

English

Submitter:

Mirella Aeberhard

Date Deposited:

25 Jun 2019 16:25

Last Modified:

23 Oct 2019 14:53

Publisher DOI:

10.1007/s00134-019-05589-y

PubMed ID:

30863936

Uncontrolled Keywords:

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

BORIS DOI:

10.7892/boris.128031

URI:

https://boris.unibe.ch/id/eprint/128031

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