P2 Trial: Preventing Kidney Injury After Heart Surgery

This study is testing if a medication called Protonix (pantoprazole) can help prevent acute kidney injury (AKI) after heart surgery. AKI is a common problem after heart surgery and can lead to worse health outcomes. Researchers believe Protonix might protect your kidneys by activating certain pathways. You could be eligible if you are an adult (18-90 years old) having planned heart surgery with a moderate to high risk of AKI. You cannot join if you have severe kidney problems, are on dialysis, need emergency surgery, or are pregnant. The study will compare Protonix to another medication called Pepcid (famotidine). Success will be measured by how many people develop AKI within 7 days of surgery or before leaving the hospital, and other kidney-related events up to 30 days after surgery. The current status of this study is unclear.

Study design
This is a randomized, controlled, single-blinded study involving 400 participants. Participants will receive either Protonix or Pepcid for 3 days.
What's involved
You would receive either Protonix or Pepcid for 3 days, starting before your heart surgery and continuing every 12 hours. Your kidney health will be monitored for up to 7 days or until hospital discharge, and for major kidney events up to 30 days after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for the incidence of Acute Kidney Injury (AKI) from enrollment to 7 days or until hospital discharge, if earlier. Major adverse kidney events (MAKE) will be monitored at day 30 postoperatively.

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NCT06706258

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

Recruiting
PHASE2Ages 18–90InterventionalPrevention
The University of Texas Health Science Center, Houston
~400 participants
Updated 2025-05-14 on ClinicalTrials.gov
What's tested:Protonix (Pantoprazole) 40 mg q 12 hrs for 3 daysPepcid (Famotidine) 20 mg q 12 hrs for 3 days

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Acute Kidney Injury (AKI)
Measured over From enrollment to 7 days or until hospital discharge, if earlier.
Acute Kidney Injury
1 sites across 1 states
Texas1
  • Yafen Liang, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

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Eligibility criteria

Inclusion

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

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

    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.