Recruiting
Phase 2

Proton Pump Inhibitor

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06706258

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Protonix (Pantoprazole) 40 mg q 12 hrs for 3 days

Pepcid (Famotidine) 20 mg q 12 hrs for 3 days

Study Details

Brief 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.

Conditions

Acute Kidney Injury

Study ID

NCT06706258

Start date

Jan 24, 2025

Status verified date

May, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Protonix (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.

Pepcid (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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Yafen Liang, MD

713-500-6226yafen.liang@uth.tmc.edu

Simon Betancourt Escobar, MD

713-500-5739simon.betancourtescobar.1@uth.tmc.edu

Locations

Memorial Hermann Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Yafen Liang, MD

713-500-6226yafen.liang@uth.tmc.edu

Simon Betancourt Escobar, MD

713-500-5739simon.betancourtescobar.1@uth.tmc.edu

Principal Investigator:

Yafen Liang, MD

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 14, 2025

Last verified

May, 2025

Keywords

  • Acute Kidney Injury
  • AKI
  • Cardiac Surgery
  • Cardiovascular Surgery
  • PPI
  • Proton Pump Inhibitors
  • Perioperative Medicine
  • Anesthesiology
  • Intensive Care Unit
  • ICU
  • Kidney

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-05-14.