Preventing kidney injury after heart surgery with a proton pump inhibitor
Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P2 Trial): A Prospective Randomized Controlled Trial
This study is testing if giving the heart surgery patients a medication called pantoprazole can help prevent kidney injuries after their surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06706258 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether administering the proton pump inhibitor pantoprazole perioperatively can reduce the incidence of acute kidney injury (AKI) in patients undergoing cardiac surgery. The study will randomly assign 400 adult patients to receive either pantoprazole or famotidine for three days following surgery. By examining molecular pathways involved in kidney protection, the trial aims to determine if pantoprazole can mitigate the risk of AKI and related adverse kidney events. The outcomes will be assessed at 30 days post-surgery, focusing on urine biomarkers and clinical events.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 scheduled for elective cardiac surgery with a moderate to high risk of developing AKI.
Not a fit: Patients with severe preoperative kidney impairment, those requiring dialysis, or those undergoing emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of acute kidney injury in patients undergoing cardiac surgery, leading to better postoperative outcomes.
How similar studies have performed: While the use of proton pump inhibitors for kidney protection is being explored, this specific approach is novel and has not been extensively tested in the context of cardiac surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (age 18-90). * Scheduled for elective cardiac surgery with cardiopulmonary bypass. * Moderate to high risk of developing AKI (Cleveland risk score equal to or higher than 3. Exclusion Criteria: * Patients with preoperative eGFR\<30 ml/min/1.73 m2 * Dialysis dependence * Emergency surgery * Pregnancy. * Nursing patient * Patients with interstitial nephritis * PPIs hypersensitivity * Liver disease * Vitamin B12 deficiency.
Where this trial is running
Houston, Texas
- Memorial Hermann Texas Medical Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Yafen Liang, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Yafen Liang, MD
- Email: yafen.liang@uth.tmc.edu
- Phone: 713-500-6226
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.