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Proton Pump Inhibitor

Pantoprazole for Acute Kidney Injury Prevention After Cardiac Surgery (P2 AKI PPI Trial)

Phase 4

Waitlist Available

Led By Yafen Liang, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients (age 18-90) scheduled for elective cardiac surgery with cardiopulmonary bypass

Be older than 18 years old

Must not have

Patients with interstitial nephritis

Patients with preoperative eGFR <30 ml/min/1.73 m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to 72 hours after icu admission

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

"This trial aims to see if giving the drug pantoprazole before and after heart surgery can help prevent kidney injury. Researchers will compare pantoprazole to a different drug, famotidine,

Who is the study for?

Adult patients over 18 years old scheduled for cardiac surgery using a cardiopulmonary bypass machine are eligible for this trial. The study specifically aims to prevent acute kidney injury post-surgery.

What is being tested?

The trial is testing if pantoprazole, a proton pump inhibitor, can protect against kidney damage after heart surgery better than famotidine. Patients will be randomly assigned to receive either pantoprazole or famotidine intravenously for two days around the time of their operation.

What are the potential side effects?

Potential side effects from pantoprazole and famotidine may include headaches, diarrhea, nausea, abdominal pain, and in rare cases more serious conditions like vitamin B12 deficiency or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 90 years old and scheduled for heart surgery with cardiopulmonary bypass.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with interstitial nephritis.

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My kidney function is low, with an eGFR under 30.

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I depend on dialysis for kidney function.

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I am scheduled for an emergency surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to 72 hours after icu admission

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to 72 hours after icu admission

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 72 hours after icu admission for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Acute Kidney Injury (AKI)

Secondary study objectives

Major Adverse Kidney Events (MAKE)

Urinary Kidney Injury Biomarkers Levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pantoprazole GroupExperimental Treatment1 Intervention

Pantoprazole (Protonix) will be given at 4 different timepoints: 1. After anesthesia induction, before surgical incision. 2. At chest closure. 3 \& 4. Every 12 hrs in post operative day 1.

Group II: Famotidine GroupActive Control1 Intervention

Famotidine (Pepcid) will be given at 4 different timepoints: 1. After anesthesia induction, before surgical incision. 2. At chest closure. 3 \& 4. Every 12 hrs in post operative day 1.

0 / 5Eligibility criteria met