A Comparison of Sucralfate and Ranitidine for the Prevention of Upper Gastrointestinal Bleeding in Patients Requiring Mechanical Ventilation
Deborah Cook, M.D., Gordon Guyatt, M.D., John Marshall, M.D., David Leasa, M.D., Hugh Fuller, M.B., Richard Hall, M.D., Sharon Peters, M.D., Frank Rutledge, M.D., Lauren Griffith, M.Sc., Allan McLellan, M.D., Gordon Wood, M.D., Ann Kirby, M.D., Martin Tweeddale, Joe Pagliarello, Richard Johnston, for The Canadian Critical Care Trials Group
Background Critically ill patients who require mechanical ventilationare at increased risk for gastrointestinal bleeding from stressulcers. There are conflicting data on the effect of histamineH2-receptor antagonists and the cytoprotective agent sucralfateon rates of gastrointestinal bleeding, ventilator-associatedpneumonia, and mortality.
Methods In a multicenter, randomized, blinded, placebo-controlledtrial, we compared sucralfate with the H2-receptor antagonistranitidine for the prevention of upper gastrointestinal bleedingin 1200 patients who required mechanical ventilation. Patientsreceived either nasogastric sucralfate suspension (1 g everysix hours) and an intravenous placebo or intravenous ranitidine(50 mg every eight hours) and a nasogastric placebo.
Results The patients in the two groups had similar base-linecharacteristics. Clinically important gastrointestinal bleedingdeveloped in 10 of 596 (1.7 percent) of the patients receivingranitidine, as compared with 23 of 604 (3.8 percent) of thosereceiving sucralfate (relative risk, 0.44; 95 percent confidenceinterval, 0.21 to 0.92; P = 0.02). In the ranitidine group,114 of 596 patients (19.1 percent) had ventilator-associatedpneumonia, as compared with 98 of 604 (16.2 percent) in thesucralfate group (relative risk, 1.18; 95 percent confidenceinterval, 0.92 to 1.51; P = 0.19). There was no significantdifference between the groups in mortality in the intensivecare unit (ICU) (23.5 percent in the ranitidine group and 22.8percent in the sucralfate group) or the duration of the stayin the ICU (median, nine days in both groups).
Conclusions Among critically ill patients requiring mechanicalventilation, those receiving ranitidine had a significantlylower rate of clinically important gastrointestinal bleedingthan those treated with sucralfate. There were no significantdifferences in the rates of ventilator-associated pneumonia,the duration of the stay in the ICU, or mortality.
Source Information
From McMaster University, Hamilton, Ont. (D.C., G.G., H.F., L.G., A.M.); the University of Toronto, Toronto (J.M.); the University of Western Ontario, London (D.L., F.R., A.K.); Dalhousie University, Halifax, N.S. (R.H.); Memorial University, St. John's, Newf. (S.P.); and Queen's University, Kingston, Ont. (G.W.) all in Canada. Other authors were Martin Tweeddale, M.D., University of British Columbia, Vancouver; Joe Pagliarello, M.D., University of Ottawa, Ottawa, Ont.; and Richard Johnston, M.D., University of Alberta, Edmonton.
Address reprint requests to Dr. Cook at the Department of Medicine, St. Joseph's Hospital, 50 Charlton Ave., Hamilton, ON L8N 4A6, Canada.
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