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Prevention study for Acute Kidney Injury
Official title Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P2 Trial)
ClinicalTrials.gov ID: NCT06706258
What this study is testing
What is Protonix (Pantoprazole) 40 mg q 12 hrs for 3 days?
Protonix (Pantoprazole) 40 mg q 12 hrs for 3 days is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute kidney injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join 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 likely can't join if
- Patients with preoperative eGFR\<30 ml/min/1.73 m2
- Dialysis dependence
- Emergency surgery
- Pregnancy.
- Nursing patient
- Patients with interstitial nephritis
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.