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

NCT06706258 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HSC-MS-24-1034
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Acute Kidney Injury (AKI)

  The investigators will calculate the incidence of acute kidney injury (AKI) within 7 days (or until hospital discharge if earlier) of cardiac surgery in patients receiving pantoprazole vs. famotidine.

  From enrollment to 7 days or until hospital discharge, if earlier.

Secondary Outcomes (2)

• Urinary Kidney Injury Biomarkers Levels

  From enrollment to 72 hours after ICU admission

• Major Adverse Kidney Events (MAKE)

  From enrollment to 30 days after cardiac surgery

Study Arms (2)

Pantoprazole Group

EXPERIMENTAL

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.

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

Famotidine Group

ACTIVE COMPARATOR

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.

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

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.

Pantoprazole Group

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.

Famotidine Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Pantoprazole; Famotidine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Azoles

Study Officials

• Yafen Liang, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yafen Liang, MD

CONTACT

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

Simon Betancourt Escobar, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.; Professor; Chief, Division of Cardiovascular Anesthesiology; Vice Chair, Clinical Research

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: January 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available and uploaded on clinicaltrials.gov website when it is due.
• Access Criteria: Accesible through the clinicaltrials.gov website.

Locations

US (1)