POP-UP
Trial question
What is the effect of pantoprazole for stress ulcer prophylaxis in critically ill patients?
Study design
Single center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 214
214 patients (74 female, 140 male).
Inclusion criteria: mechanically ventilated critically ill patients suitable for enteral nutrition.
Key exclusion criteria: acid-suppressive therapy prior to admission, gastrointestinal bleeding, history of proven peptic ulcer disease, administration of > 100 mg daily of prednisolone (or equivalent of other corticosteroid), surgery on the upper gastrointestinal tract or cardiac surgery during the current hospital admission, or pregnancy.
Interventions
N=106 pantoprazole (intravenous infusion of 40 mg in 10 mL of 0.9% saline).
N=108 placebo (intravenous infusion of 10 mL of 0.9% saline).
Primary outcome
Death at 90 days
28.3%
23.1%
28.3 %
21.2 %
14.2 %
7.1 %
0.0 %
Pantoprazole
Placebo
No significant
difference ↔
No significant difference in death at 90 days (28.3% vs. 23.1%; aHR 1.68, 95% CI 0.97 to 2.9).
Secondary outcomes
No significant difference in length of hospital stay (16 days vs. 18 days; AD -2 days, 95% CI -26.07 to 22.07).
Safety outcomes
No significant differences in ventilator-associated pneumonia, overt bleeding.
Conclusion
In mechanically ventilated critically ill patients suitable for enteral nutrition, pantoprazole was not superior to placebo with respect to death at 90 days.
Reference
Selvanderan SP, Summers MJ, Finnis ME et al. Pantoprazole or Placebo for Stress Ulcer Prophylaxis (POP-UP): Randomized Double-Blind Exploratory Study. Crit Care Med. 2016 Oct;44(10):1842-50.
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