A COMPARISON OF SUCRALFATE AND RANITIDINE FOR THE PREVENTION OF UPPERGASTROINTESTINAL-BLEEDING IN PATIENTS REQUIRING MECHANICAL VENTILATION

Background Critically ill patients who require mechanical ventilation are at increased risk for gastrointestinal bleeding from stress ulcers . There are conflicting data on the effect of histamine H-2-receptor a ntagonists and the cytoprotective agent sucralfate on rates of gastroi ntestinal bleeding, ventilator-associated pneumonia, and mortality. Me thods In a multicenter, randomized, blinded, placebo-controlled trial, we compared sucralfate with the H-2-receptor antagonist ranitidine fo r the prevention of upper gastrointestinal bleeding in 1200 patients w ho required mechanical ventilation. Patients received either nasogastr ic sucralfate suspension (1 g every six hours) and an intravenous plac ebo or intravenous ranitidine (50 mg every eight hours) and a nasogast ric placebo. Results The patients in the two groups had similar base-l ine characteristics. Clinically important gastrointestinal bleeding de veloped in 10 of 596 (1.7 percent) of the patients receiving ranitidin e, as compared with 23 of 604 (3.8 percent) of those receiving sucralf ate (relative risk, 0.44; 95 percent confidence interval, 0.21 to 0.92 ; P = 0.02). In the ranitidine group, 114 of 596 patients (19.1 percen t) had ventilator-associated pneumonia, as compared with 98 of 604 (16 .2 percent) in the sucralfate group (relative risk, 1.18; 95 percent c onfidence interval, 0.92 to 1.51; P = 0.19). There was no significant difference between the groups in mortality in the intensive care unit (ICU) (23.5 percent in the ranitidine group and 22.8 percent in the su cralfate group) or the duration of the stay in the ICU (median, nine d ays in both groups). Conclusions Among critically ill patients requiri ng mechanical ventilation, those receiving ranitidine had a significan tly lower rate of clinically important gastrointestinal bleeding than those treated with sucralfate. There were no significant differences i n the rates of ventilator-associated pneumonia, the duration of the st ay in the ICU, or mortality. (C) 1998, Massachusetts Medical Society.