drugset / Trial / NCT06706258

Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P2 Trial)

NCT06706258

RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2025-01-24
Primary completion
2026-12-01
Completion
2027-07-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Famotidine Other / unclassified 20 mg
Subject Pantoprazole Other / unclassified 40 mg Intravenous

Indications