Objective: To determine the efficacy and safety of cimetidine and sucralfate prophylaxis for stress-related gastrointestinal hemorrhage in patients admitted to a medical intensive care unit.
Setting: Medical intensive care unit of a nonprofit, university-affiliated teaching hospital.
Patients: 300 patients admitted to the medical intensive care unit during a 10-month period.
Design: Randomized, controlled, single-blind clinical trial.
Intervention: Patients were assigned to receive no prophylaxis (control), 1 g sucralfate given orally every 6 hours, or continuous intravenous cimetidine titrated to maintain gastric pH at 4.0, intervention was maintained until the occurrence of clinically severe hemorrhage, onset of drug-related complications, death, or discharge from the medical intensive care unit.
Outcome measures: The primary outcome measure was the incidence of clinically severe hemorrhage from endoscopically verified stress-related gastritis. Other outcome measures were transfusion requirements, duration of medical intensive care unit stay, incidence of nosocomial pneumonia, adverse drug reactions, and death.
Results: 100 patients were randomly assigned to each treatment. The three groups were similar with regard to demographic characteristics, 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 compared 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 mortality rates among the three groups. Nosocomial pneumonia was diagnosed in 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.
Conclusions: The observed effects of cimetidine and sucralfate on the incidence 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 does not seem warranted.