REVISE
Trial question
What is the role of pantoprazole in patients undergoing invasive ventilation?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 4821
4821 patients (1753 female, 3068 male).
Inclusion criteria: critically ill adults who were undergoing invasive ventilation.
Key exclusion criteria: initiation of invasive ventilation > 72 hours before randomization; receipt of > 1 daily-dose equivalent of acid suppression in the ICU; indication or contraindication of acid suppression.
Interventions
N=2417 pantoprazole (intravenous dose of 40 mg daily).
N=2404 placebo (0.9% sodium chloride IV).
Primary outcome
Clinically important upper gastrointestinal bleeding
1%
3.5%
3.5 %
2.6 %
1.8 %
0.9 %
0.0 %
Pantoprazole
Placebo
Significant
decrease ▼
NNT = 40
Significant decrease in clinically important upper gastrointestinal bleeding (1% vs. 3.5%; HR 0.3, 95% CI 0.19 to 0.47).
Secondary outcomes
No significant difference in ventilator-associated pneumonia in the ICU (23.2% vs. 23.8%; HR 1, 95% CI 0.89 to 1.12).
No significant difference in C. difficile infection in the hospital (1.2% vs. 0.7%; HR 1.78, 95% CI 0.96 to 3.29).
Significant decrease in patient-important upper gastrointestinal bleeding in the ICU (1.5% vs. 4.2%; HR 0.36, 95% CI 0.25 to 0.53).
Safety outcomes
No significant difference in death at day 90.
Conclusion
In critically ill adults who were undergoing invasive ventilation, pantoprazole was superior to placebo with respect to clinically important upper gastrointestinal bleeding.
Reference
Deborah Cook, Adam Deane, François Lauzier et al. Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation. N Engl J Med. 2024 Jul 4;391(1):9-20.
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