Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P2 Trial): A Prospective Randomized Controlled Trial
The University of Texas Health Science Center, Houston
Summary
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.
Description
Each year more than 500,000 cardiac surgeries are performed in the USA alone. AKI is a common complication following cardiac surgery and is associated with poor patient outcome and increased health care cost. Therefore, there is an urgent need to identify medical interventions and treatments that prevent AKI or mitigate its severity when it occurs after cardiac surgery. One of the main causes of AKI following cardiac surgery involves renal hypoperfusion/ischemia and reperfusion injury. Hypoxia inducible factors (HIFs) are key transcription factors responsible for tissue adaptation to low oxyg…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- DrugProtonix (Pantoprazole) 40 mg q 12 hrs for 3 days
Administer 1st dose after anesthesia induction before surgical incision, 2nd dose at chest closure. Then, every 12 hrs for 2 more days.
- DrugPepcid (Famotidine) 20 mg q 12 hrs for 3 days
Administer 1st dose after anesthesia induction before surgical incision, 2nd dose at chest closure. Then, every 12 hrs for 2 more days.
Location
- Memorial Hermann Texas Medical CenterHouston, Texas