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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.