CompletedPhase 2

Prevention of Post-Cardiac Surgery Acute Kidney Injury by Proton Pump Inhibitor

United States100 participantsStarted 2024-01-10

Plain-language summary

The purpose of this study is to determine whether perioperative intravenous administration of pantoprazole will improve kidney function parameters following cardiac surgery with cardiopulmonary bypass compared to famotidine and to determine whether perioperative intravenous administration of pantoprazole will decrease the incidence of postoperative Acte Kidney Injury (AKI) and major adverse kidney events (MAKE).

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion Criteria: * Scheduled for elective cardiac surgery with cardio pulmonary bypass (CPB) with a moderate to high risk of developing AKI (Cleveland risk score equal or higher than 3) Exclusion Criteria: * Preoperative eGFR\<30 ml/min per 1.73 m2 * Dialysis dependence * Emergency surgery * Pregnancy * Nursing Patients * Interstitial nephritis * Proton pump inhibitors (PPIs) hypersensitivity * Liver disease * Vitamin B12 deficiency

What they're measuring

Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Kidney Injury Molecule-1 (KIM-1) Above Baseline Within 24 Hours Postoperatively

Timeframe: from baseline (time 0) to 24 hours postoperatively

Trial details

NCT IDNCT06154226

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-17

Results submitted2025-09-16

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