Home › Acute Kidney Injury › NCT06706258
Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P2 Trial)
Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P2 Trial): A Prospective Randomized Controlled Trial
Who can join
Ages 18 to 90 · All sexes
Full eligibility 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.
About the study
The central hypothesis of this research study is that perioperative administration of the proton pump inhibitor (PPI) pantoprazole could reduce the development of acute kidney injury (AKI) following cardiac surgery by activation molecular pathways for kidney protection. The investigators propose a single-center, randomized, controlled, single-blinded trial to determine whether perioperative intravenous administration of pantoprazole will reduce the incidence of AKI, some molecules that can be detected the urine, and major adverse kidney events (MAKE) at day 30 postoperatively, compared to famotidine after cardiac surgery. The specific aims of the study will be achieved by randomizing a group of 400 patients to receive pantoprazole (study) or famotidine (control) for 3 days perioperatively.
Our study population will include any adult patients (aged over 18 years) scheduled for cardiac surgery requiring a cardiopulmonary bypass machine.
What is being tested
- Protonix (Pantoprazole) 40 mg q 12 hrs for 3 days (drug)
- Pepcid (Famotidine) 20 mg q 12 hrs for 3 days (drug)
Sponsor: The University of Texas Health Science Center, Houston · Participants: 400 · Started: Jan 24, 2025
Contact the study team
- Yafen Liang, MD · Phone: 713-500-6226
- Simon Betancourt Escobar, MD · Phone: 713-500-5739
Official record on ClinicalTrials.gov — NCT06706258
Locations in the U.S.
| Texas | Memorial Hermann Texas Medical Center, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.