A study led by researchers at McMaster University has confirmed that a widely available drug can help prevent upper gastrointestinal bleeding in critically ill adults on a breathing machine.
The results of the research, which were published on June 14, 2024 in The New England Journal of Medicine and NEJM Evidence, looked into the impact of gastric acid suppression on the prevention of stress-induced upper gastrointestinal bleeding in critically ill patients.
The drug pantoprazole is mainly used to treat heartburn from GERD. In the ICU, patients on mechanical ventilators also receive pantoprazole to prevent upper gastrointestinal bleeding from stress-induced ulcers in the stomach. There were concerns about whether this complication of critical illness had decreased over the years and about the side effects of pantoprazole, including an increased risk of death in the sickest patients. The research offers critical care teams clarity on whether the medication should be used in practice.
“This is the largest randomized trial on this topic in the world, led by Canada. Physicians, nurses, and pharmacists working in the ICU setting will use this information in practice right away, and the trial results and the updated meta-analysis will be incorporated into international practice guidelines,” said lead author and principal investigator Deborah Cook, a professor in the Department of Medicine at McMaster.
Global randomized control trial
The Reevaluating the Inhibition of Stress Erosions (REVISE) Trial was a randomized control trial that compared the effect of pantoprazole to placebo in critically ill patients.All adults on a breathing machine were included in the trial, which took place in 68 centers across eight countries and involved over 4,800 patients. Among those receiving invasive ventilation, pantoprazole was found to reduce the risk of clinically important upper gastrointestinal bleeding compared to a placebo, although it did not lead to a lower risk of death.
Specifically, one percent of patients (25 out of 2,417) receiving pantoprazole experienced clinically important upper gastrointestinal bleeding, while nearly four percent (84 out of 2,404) of those receiving the placebo experienced the same. After 90 days, 29 percent (696 out of 2,390) of patients in the pantoprazole group had died, compared to 31 percent (734 out of 2,379) in the placebo group.patients (30 percent) in the placebo group.
Updated systematic review
Scientists conducted a meta-analysis of 12 randomized trials of proton-pump inhibitors for GI bleeding prevention in 10,000 critically ill patients to summarize the current evidence on the outcomes of gastrointestinal bleeding, mortality, pneumonia and C. difficile infection.
The medications were linked to a decreased occurrence of clinically important upper gastrointestinal bleeding and may potentially have minimal impact on mortality. The evidence also suggested that the medications may not have any effect.The study found that the vaccine showed promising results in preventing pneumonia but did not have much impact on C. difficile infection. The research was supported by various organizations including the Canadian Institutes for Health Research, the Accelerating Clinical Trials Fund, Physicians Services Incorporated of Ontario, Hamilton Association of Health Sciences Organization, and the National Health Medical Research Council of Australia.