Actively Recruiting
Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P2 Trial)
Led by The University of Texas Health Science Center, Houston · Updated on 2025-05-14
400
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P2 Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 to 90 years
- Scheduled for elective cardiac surgery with cardiopulmonary bypass
- Moderate to high risk of developing acute kidney injury (Cleveland risk score of 3 or higher)
You will not qualify if you...
- Patients with preoperative estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73 m2
- Dialysis dependence
- Emergency surgery
- Pregnancy
- Nursing patients
- Patients with interstitial nephritis
- Hypersensitivity to proton pump inhibitors
- Liver disease
- Vitamin B12 deficiency
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Memorial Hermann Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Y
Yafen Liang, MD
CONTACT
S
Simon Betancourt Escobar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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