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Results of a Double-blind Clinical Trial

Kimberly S. Ephgrave, MD; Rachel Kleiman-Wexler, PharmD; Michael Pfaller, MD; Brenda M. Booth, PhD; David Reed, PhD; Lisa Werkmeister, RN; Sharon Young

Arch Surg. 1998;133:251-257.

Background  Unblinded studies suggested that sucralfate prophylaxis for stress ulcers is associated with a lower rate of nosocomial pneumonia than acid-reducing approaches. We performed a randomized, double-blind, double-sham clinical trial comparing the exact microbial effects of each treatment.

Methods  One hundred forty patients entered this study before major elective surgery, allowing baseline cultures of gastric and pulmonary secretions to be obtained intraoperatively. Postoperatively, the patients were treated with standard doses of either sucralfate or antacids, plus a sham of the other drug. Cultures were repeated twice daily for 3 days. Molecular epidemiological typing was used to track the appearance of specific microbes and their transmission from site to site, and clinical end points were compared. The number of patients chosen was for sufficient statistical power to detect differences in the microbial measures, as detecting differences in clinical measures would have required increasing the sample size by an order of magnitude.

Results  Gastric pH was affected by the form of stress ulcer prophylaxis throughout the study, and this pH effect affected the number of new gastric organisms appearing in the 2 different groups. Colonization of the airway with new gastric organisms occurred more frequently in the antacid than in the sucralfate group, and colonization of the airway with organisms of gastric origin was associated with occurrence of postoperative pneumonia.

Conclusions  Both sucralfate and antacids offered safe and effective stress ulcer prophylaxis in this double-blind clinical trial of postoperative patients in an intensive care unit. In association with the drug's effects on gastric pH, more new pathogens appeared in the gastric contents of antacid-treated than sucralfate-treated patients.

From the Surgical Service, Veterans Affairs Medical Center, Iowa City, Iowa (Drs Ephgrave, Kleiman-Wexler, Pfaller, Booth, and Reed and Mss Werkmeister and Young); Colleges of Medicine (Drs Ephgrave and Pfaller), Pharmacy (Dr Kleiman-Wexler), and Nursing (Dr Reed), University of Iowa, Iowa City; and Veterans Affairs Medical Center, Little Rock, Ark (Dr Booth).

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