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June 14, 2024

Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation

Mazen Kherallah

Summarized by: 

Critically ill adults undergoing invasive mechanical ventilation in the ICU.

Intravenous pantoprazole at a dose of 40 mg daily.

Matching placebo.


  • Primary Efficacy Outcome: Clinically important upper gastrointestinal bleeding.

  • Primary Safety Outcome: Death from any cause at 90 days.

  • Key Secondary Outcomes: Ventilator-associated pneumonia, Clostridioides difficile infection, and patient-important bleeding.

Study Methods

  • Design: International, randomized, blinded trial.

  • Participants: 4821 patients from 68 ICUs in various countries.

  • Duration: 90 days follow-up.

  • Randomization: Patients assigned to pantoprazole or placebo groups.

  • Blinding: Trial-group assignments were blinded to patients, their families, clinical and research staff, outcome adjudicators, and biostatisticians.


  • Clinically Important Upper Gastrointestinal Bleeding: Occurred in 25 of 2385 patients (1.0%) in the pantoprazole group and 84 of 2377 patients (3.5%) in the placebo group (HR, 0.30; 95% CI, 0.19 to 0.47; P<0.001).

  • Death from Any Cause at 90 Days: Reported in 696 of 2390 patients (29.1%) in the pantoprazole group and 734 of 2379 patients (30.9%) in the placebo group (HR, 0.94; 95% CI, 0.85 to 1.04; P=0.25).

  • Secondary Outcomes:Ventilator-associated pneumonia: Similar in both groups (23.2% vs. 23.8%).
    C. difficile infection: Slightly higher in the pantoprazole group (1.2% vs. 0.7%).
    Patient-important bleeding: Reduced in the pantoprazole group (1.5% vs. 4.2%; HR, 0.36; 95% CI, 0.25 to 0.53; P<0.001).


Pantoprazole significantly reduced the risk of clinically important upper gastrointestinal bleeding in critically ill patients undergoing invasive mechanical ventilation, with no significant effect on mortality. Secondary outcomes such as ventilator-associated pneumonia and C. difficile infection were similar between groups, but pantoprazole was associated with a reduction in patient-important bleeding.


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