PROPHYLAXIS FOR STRESS-RELATED GASTRIC HEMORRHAGE IN THE MEDICAL INTENSIVE-CARE UNIT - A RANDOMIZED, CONTROLLED, SINGLE-BLIND STUDY

Objective: To determine the efficacy and safety of cimetidine and sucr alfate prophylaxis for stress-related gastrointestinal hemorrhage in p atients admitted to a medical intensive care unit. Setting: Medical in tensive care unit of a nonprofit, university-affiliate teaching hospit al. Patients: 300 patients admitted to the medical intensive care unit during a 10-month period. Design: Randomized, controlled, single-blin d clinical trial. Intervention: Patients were assigned to receive no p rophylaxis (control), 1 g sucralfate given orally every 6 hours, or co ntinuous intravenous cimetidine titrated to maintain gastric pH at 4.0 . Intervention was maintained until the occurrence of clinically sever e hemorrhage, onset of drug-related complications, death, or discharge from the medical intensive care unit. Outcome Measures: The primary o utcome measure was the incidence of clinically severe hemorrhage from endoscopically verified stress-related gastritis. Other outcome measur es were transfusion requirements, duration of medical intensive care u nit stay, incidence of nosocomial pneumonia, adverse drug reactions, a nd death. Results: 100 patients were randomly assigned to each treatme nt. The three groups were similar with regard to demographic character istics, intensive care unit admission diagnoses, and APACHE II scores. Stress-related hemorrhage was seen in 6% of control participants and in 5% of those receiving sucralfate or cimetidine (relative risk compa red with control, 0.83 for each group; 95% CI, 0.26 to 2.64; P = 0.75) . No statistically significant differences were found for transfusion requirements, duration of medical intensive care unit stay, and mortal ity rates among the three groups. Nosocomial pneumonia was diagnosed i n 6%, 12%, and 13% of controls, sucralfate recipients, and cimetidine recipients, respectively (sucralfate: relative risk, 2.0 [CI, 0.79 to 5.01], P = 0.14; cimetidine: relative risk, 2.2 [CI, 0.88 to 5.33], P = 0.09). Prophylaxis caused no definite adverse drug reactions. Conclu sions: The observed effects of cimetidine and sucralfate on the incide nce and severity of hemorrhage from stress-related gastritis were not significant when compared with no treatment. Routine prophylaxis with these agents for patients entering the medical intensive care unit doe s not seem warranted.