Respiratory Trials·org

Gastroenterology in critical care · Stress ulcer prophylaxis

REVISE randomised trial

Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation

REVISE trial design and results
Design Multicentre randomised controlled trial in 68 ICUs
Treatment Intravenous pantoprazole
Control Placebo
Population 4821 patients undergoing invasive mechanical ventilation
Follow-up 90 days
Primary endpoint Clinically important upper gastrointestinal bleeding
Result Clinically important upper gastrointestinal bleeding occurred in 25 of 2385 (1.0%) receiving pantoprazole and 84 of 2377 (3.5%) receiving placebo, with no significant effect on mortality.
Secondary endpoints 90-day mortality, ventilator-associated pneumonia, Clostridioides difficile infection

Among patients undergoing invasive ventilation, pantoprazole resulted in a significantly lower risk of clinically important upper gastrointestinal bleeding than placebo, with no significant effect on mortality.

The trial authors, in the published abstract

How it has aged

Definitively re-establishes stress ulcer prophylaxis after years of doubt about whether modern enterally fed patients still need it. The absence of a mortality signal in either direction is reassuring on the infection concerns that drove the doubt.

Publications

Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation

Cook D, Deane A, Lauzier F, et al. Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation. N Engl J Med 2024 Jul 4;391(1):9-20.

  • Clinically important bleeding 1.0% versus 3.5%
  • No effect on mortality
  • 4821 patients across 68 ICUs