Impact of multiple risk factors and ranitidine prophylaxis on the development of stress-related upper gastrointestinal bleeding: A prospective, multicenter, double-blind, randomized trial

C. A. Metz, D. H. Livingston, J. S. Smith, G. M. Larson, T. H. Wilson, G. M. Larson, D. H. Livingston, J. S. Smith, D. E. Fry, C. Veremakis, R. MacKersie, J. A. Weigelt, T. J. Gallagher, P. Perot, C. A. Metz, K. H. Crawford, T. H. Wilson

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66 Scopus citations

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 ≤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.

Original languageEnglish (US)
Pages (from-to)1844-1849
Number of pages6
JournalCritical care medicine
Volume21
Issue number12
DOIs
StatePublished - 1993
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Critical Care and Intensive Care Medicine

Keywords

  • Glasgow Coma Scale
  • gastrointestinal, hemorrhage
  • head injury
  • nosocomial pneumonia
  • prophylaxis
  • ranitidine, continuous infusion
  • stress, gastric
  • trauma

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