RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P2 Trial): A Prospective Randomized Controlled Trial

Quick Facts

Study Start:2025-01-24
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06706258

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients (age 18-90).
  2. * Scheduled for elective cardiac surgery with cardiopulmonary bypass.
  3. * Moderate to high risk of developing AKI (Cleveland risk score equal to or higher than 3.
  1. * Patients with preoperative eGFR\<30 ml/min/1.73 m2
  2. * Dialysis dependence
  3. * Emergency surgery
  4. * Pregnancy.
  5. * Nursing patient
  6. * Patients with interstitial nephritis
  7. * PPIs hypersensitivity
  8. * Liver disease
  9. * Vitamin B12 deficiency.

Contacts and Locations

Study Contact

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

Principal Investigator

Yafen Liang, MD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

Memorial Hermann Texas Medical Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Yafen Liang, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-24
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2025-01-24
Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Acute Kidney Injury