RecruitingPhase 2NCT06706258

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

400 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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.

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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.


Locations(1)

Memorial Hermann Texas Medical Center

Houston, Texas, United States

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NCT06706258


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