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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06706258
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Protonix (Pantoprazole) 40 mg q 12 hrs for 3 days — DRUG
    Administer 1st dose after anesthesia induction before surgical incision, 2nd dose at chest closure. Then, every 12 hrs for 2 more days.
  • Pepcid (Famotidine) 20 mg q 12 hrs for 3 days — DRUG
    Administer 1st dose after anesthesia induction before surgical incision, 2nd dose at chest closure. Then, every 12 hrs for 2 more days.

Study Details

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.

Key Dates

Start date
Jan 24, 2025
Status verified
May 2025
Primary completion
Dec 1, 2026
Completion
Jul 1, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Pantoprazole Group
    Pantoprazole (Protonix) will be given at 6 different timepoints: 1. After anesthesia induction, before surgical incision. 2. At chest closure. 3 \& 4. Every 12 hrs in post operative day 1. 5 \& 6. Every 12 hrs in post operative day 2.
  • Active Comparator: Famotidine Group
    Famotidine (Pepcid) will be given at 6 different timepoints: 1. After anesthesia induction, before surgical incision. 2. At chest closure. 3 \& 4. Every 12 hrs in post operative day 1. 5 \& 6. Every 12 hrs in post operative day 2.

Primary Outcome Measure

Incidence of Acute Kidney Injury (AKI) [ Time Frame: From enrollment to 7 days or until hospital discharge, if earlier. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Hermann Texas Medical CenterHoustonTexas77030
Yafen Liang, MD
[email protected]
713-500-6226
Simon Betancourt Escobar, MD
[email protected]
713-500-5739
Yafen Liang, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Memorial Hermann Texas Medical Center· Houston, TX

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