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Crit Care Med. 1993 Dec;21(12):1844-9.

Impact of multiple risk factors and ranitidine prophylaxis on the development of stress-related upper gastrointestinal bleeding: a prospective, multicenter, double-blind, randomized trial. The Ranitidine Head Injury Study Group.

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1
Glaxo Pharmaceuticals, Research Triangle Park, NC 27709.

Abstract

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.

[Indexed for MEDLINE]

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