Tamir Ben-Menachem, MD; Ronald Fogel, MD; Rakesh V. Patel, PharmD; Mark Touchette, PharmD; Barbara J. Zarowitz, PharmDMD; Neven Hadzijahic, MD; George Divine, PhD; Joel Verter, PhD; Robert S. Bresalier, MD
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.
Medical intensive care unit of a nonprofit, university-affiliated teaching hospital.
300 patients admitted to the medical intensive care unit during a 10-month period.
Randomized, controlled, single-blind clinical trial.
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.
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.
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.
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.
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Ben-Menachem T, Fogel R, Patel RV, Touchette M, Zarowitz BJ, Hadzijahic N, et al. Prophylaxis for Stress-related Gastric Hemorrhage in the Medical Intensive Care Unit: A Randomized, Controlled, Single-Blind Study. Ann Intern Med. 1994;121:568-575. doi: 10.7326/0003-4819-121-8-199410150-00003
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Published: Ann Intern Med. 1994;121(8):568-575.
Hospital Medicine, Prevention/Screening, Pulmonary/Critical Care.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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