Respiratory failure & ventilation

Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation

N Engl J MedPublished Randomised controlled trial

Primary result · Clinically important upper GI bleeding in the ICUResult — go to the resultHazard ratio 0.30 95% CI 0.19–0.47

Authors' conclusion

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.

Study context

Population
Critically ill adults undergoing invasive ventilation
Participants
4,821 adults · 68 intensive care unit (ICUs)
Comparison
IV pantoprazole 40 mg daily vs placebo
Primary endpoint
Clinically important upper GI bleeding in the ICU (primary efficacy outcome); primary safety outcome death from any cause at 90 days
Follow-up
90 days
Methodological detailsinternational, placebo-controlled
  • International
  • Placebo-controlled

Primary result

As reported in the abstract

Clinically important upper GI bleeding in the ICU

Hazard ratio

0.30

95% CI 0.19–0.47

P < 0.001

Events by treatment group

Pantoprazole vs Placebo
HR 0.30 (95% CI 0.19–0.47); P < 0.001

Secondary outcomes

OutcomePantoprazolePlaceboHR (95% CI)P value
Death from any cause (primary safety outcome) · 90 daysDenominators 2390 vs 237929.1%30.9%0.94 (0.85–1.04)P = 0.25

Patient-important bleeding

Reduced with pantoprazole

Other secondary outcomes (incl. VAP, Clostridioides difficile infection)

Similar in the two groups
  • Multiplicity-adjusted

Original publication

Stress Ulcer Prophylaxis during Invasive Mechanical Ventilation. N Engl J Med. Published 14 June 2024. doi:10.1056/nejmoa2404245

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