A Prospective, Randomized, Double-Blind Protocol to Compare the Efficacy of Lansoprazole to Ranitidine in Healing Pre-Existing and/or Preventing the Development of Gastroduodenal Stress Ulceration and Postoperative Bleeding in Patients Undergoing Elective Coronary Artery Bypass Graft or Cardiac Valve Replacement Surgery
Abstract
The primary objective of this study is to determine whether lansoprazole, administered intravenously, can protect patients undergoing cardiac surgery from the development of and/or progression of previously undetected acid/peptic disorders (erosive esophagitis, gastric ulcer, duodenal ulcer, diffuse gastritis, duodenitis) as measured by the Lanza score and LA classification for esophageal injury.
The secondary objectives of this study are:
1. To determine if intravenous lansoprazole protects against the development of clinically important gastrointestinal bleeding in this population (overt bleeding or requiring blood transfusion).
2. To determine if intravenous lansoprazole maintains the intragastric pH above that for placebo throughout the study period.
Conditions: Patients Undergoing Elective Coronary Artery Bypass Graft.
Primary outcome: Mucosal Erosions.
Enrollment: 40 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 40 participants or records.
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