Lansoprazole Preventing Gastroduodenal Stress Ulcerations

• Status: Terminated
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

Patients with symptomatic coronary artery disease or valvular heart disease who require corrective cardiac surgery will be eligible to participate in this study.

Inclusion Criteria:

• Patients undergoing cardiovascular surgery, specifically elective coronary artery bypass graft or cardiac valve replacement surgery, at Temple University Hospital

• Able to provide informed consent

Exclusion Criteria:

• Evidence of active gastrointestinal bleeding

• Prior gastric (e.g. Billroth II) or esophageal surgery

• Pregnancy

• Pre-existing or current condition requiring acid-suppressive therapy - e.g. reflux esophagitis, gastric or duodenal ulcer

• Current use of acid-suppressive therapy, such as proton pump inhibitors or histamine type 2 receptor antagonists

• Contraindication to naso- or oro-gastric intubation (e.g. Zenker's diverticulum, esophageal stricture)

• Bleeding diathesis

• Allergy to lansoprazole

• Advanced renal disease (BUN>40 and/or creatinine>2.0.

• Advanced liver disease (Alkaline phosphatase, ALT, AST>2 x normal)