SUP-ICU
Trial question
What is the role of pantoprazole in patients at risk for gastrointestinal bleeding in the ICU?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 3298
3298 patients (1185 female, 2106 male)
Inclusion criteria: adult patients admitted to the ICU for an acute condition who were at risk for gastrointestinal bleeding
Key exclusion criteria: ongoing daily treatment with acid suppressants, gastrointestinal bleeding during index hospital admission, withdrawn from active therapy or brain dead, organ transplantation during index hospital admission, peptic ulcer, contraindication to pantoprazole, pregnant
Interventions
N=1645 pantoprazole (intravenous injection of 40 mg suspended in 10 ml of 0.9% sodium chloride daily for a maximum of 90 days)
N=1653 placebo (intravenous injection of matching placebo suspended in 10 ml of 0.9% sodium chloride daily for a maximum of 90 days)
Primary outcome
Death at 90 days
31.1
30.4
31.1 %
23.3 %
15.6 %
7.8 %
0.0 %
Pantoprazole
Placebo
No significant
difference ↔
No significant difference in death at 90 days (31.1% vs. 30.4%; RR 1.02, 95% CI 0.91 to 1.13)
Secondary outcomes
No significant difference in clinically important gastrointestinal bleeding, pneumonia, C. difficile infection, or myocardial ischemia, during the ICU stay (21.9% vs. 22.6%; RR 0.96, 96% CI 0.83 to 1.11)
Safety outcomes
No significant differences in serious adverse reactions, number of patients with infections and days alive without life support within 90 days.
Conclusion
In adult patients admitted to the ICU for an acute condition who were at risk for gastrointestinal bleeding, pantoprazole was not superior to placebo with respect to death at 90 days.
Reference
Krag M, Marker S, Perner A et al. Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU. N Engl J Med. 2018 Dec 6;379(23):2199-2208.
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