Status:
TERMINATED
Lansoprazole Preventing Gastroduodenal Stress Ulcerations
Lead Sponsor:
Temple University
Conditions:
Patients Undergoing Elective Coronary Artery Bypass Graft
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 prev...
Detailed Description
This is a randomized, double-blind single center study which compares the efficacy of lansoprazole by IV infusion daily (60 mg bolus followed by 6 mg per hour) compared to ranitidine 50 mg IV q12 h in...
Eligibility Criteria
Inclusion
- Patients with symptomatic coronary artery disease or valvular heart disease who require corrective cardiac surgery will be eligible to participate in this study.
- 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
- 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)
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00220909
Start Date
September 1 2005
End Date
January 1 2006
Last Update
January 11 2008
Active Locations (1)
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1
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140