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The New England Journal of MedicineStress Ulcer Prophylaxis during Invasive Mechanical Ventilation

Evaluating the impact of pantoprazole on preventing upper gastrointestinal bleeding in mechanically ventilated ICU patients and its broader implications for ICU management and patient outcomes.

This international, randomized trial assessed the efficacy and safety of intravenous pantoprazole for stress ulcer prophylaxis in critically ill patients undergoing invasive mechanical ventilation. The study involved 4,821 patients across 68 ICUs and compared pantoprazole to a placebo, focusing on clinically important upper gastrointestinal bleeding and overall mortality at 90 days, along with secondary outcomes like ventilator-associated pneumonia and Clostridioides difficile infection.

Study Design:

  • Participants: 4821 critically ill adults undergoing invasive mechanical ventilation.
  • Setting: 68 intensive care units (ICUs) internationally.
  • Intervention: Intravenous pantoprazole (40 mg daily) versus matching placebo.
  • Primary Efficacy Outcome: Clinically important upper gastrointestinal bleeding in the ICU at 90 days.
  • Primary Safety Outcome: Death from any cause at 90 days.
  • Key Secondary Outcomes: Ventilator-associated pneumonia, Clostridioides difficile infection, and patient-important bleeding, with adjustments for multiplicity.

Key Findings

  • Upper Gastrointestinal Bleeding: Occurred in 1.0% (25/2385) of patients receiving pantoprazole compared to 3.5% (84/2377) of patients receiving placebo (hazard ratio, 0.30; 95% CI, 0.19 to 0.47; P<0.001).
  • Mortality at 90 Days: 29.1% (696/2390) in the pantoprazole group and 30.9% (734/2379) in the placebo group (hazard ratio, 0.94; 95% CI, 0.85 to 1.04; P=0.25).
  • Patient-Important Bleeding: Reduced in the pantoprazole group.
  • Ventilator-Associated Pneumonia and Clostridioides Difficile Infection: No significant differences between the groups.

HCN Medical Memo
The use of intravenous pantoprazole for stress ulcer prophylaxis in critically ill patients undergoing mechanical ventilation effectively reduces the risk of upper gastrointestinal bleeding. Physicians should consider this intervention to enhance patient outcomes without increasing mortality or other significant complications.

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