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Impact of multiple risk factors and ranitidine prophylaxis on the development of stress-related upper
C A Metz1, D H Livingston, J S Smith
1Glaxo Pharmaceuticals, Research Triangle Park, NC 27709.
Objectives:
To evaluate the impact of risk factors on the development of stress-related upper gastrointestinal bleeding in severe head injury patients randomized to treatment with a 6.25 mg/hr continuous ranitidine infusion or placebo.
Design:
Prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group study.
Setting:
Ten intensive care units in the United States.
Patients:
Patients with severe head injury, defined as having a Glasgow Coma Score of < or = 10, were eligible for enrollment.
Interventions:
Ranitidine 6.25 mg/hr or saline placebo was administered by continuous infusion for a maximum of 5 days.
Measurements And Main Results:
Patients were evaluated every 8 hrs for the presence of stress-related upper gastrointestinal bleeding. Bleeding developed in 15 (19%) of 81 placebo-treated patients vs. three (3%) of 86 ranitidine-treated patients (p = .002). None of the individual risk factors had a significant effect on bleeding frequency. No bleeding occurred in the four patients with one risk factor. Placebo bleeding rates in patients with 2, 3 to 5, and > 5 risk factors were 20%, 20%, and 18%, respectively. For the ranitidine-treated patients, bleeding was reported in 0%, 5%, and 0% in the 2, 3 to 5, and > 5 risk factor subgroups, respectively. Pneumonia occurred in 19% of the placebo-treated patients vs. 14% in the ranitidine treatment group.
Conclusions:
The full risk to develop stress-related upper gastrointestinal bleeding was realized when two risk factors were present concomitantly. The presence of additional risk factors did not increase the occurrence of bleeding. A continuous infusion of ranitidine at 6.25 mg/hr provided significant protection from bleeding, regardless of the number of risk factors present.
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