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Proton Pump Inhibitor

Pantoprazole for Acute Kidney Injury Prevention Post-Cardiac Surgery

Phase 4

Recruiting

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

Scheduled for elective cardiac surgery with cardio pulmonary bypass (CPB) with a high risk of developing AKI (Cleveland risk score higher than 6, please see the appended table at end of the revised protocol)

Be older than 18 years old

Must not have

Emergency surgery

Dialysis dependence

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after surgery

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test if pantoprazole can protect kidney function during cardiac surgery and reduce risks of AKI and MAKE.

Who is the study for?

This trial is for adults scheduled for elective cardiac surgery with a high risk of acute kidney injury (AKI), as indicated by a Cleveland risk score over 6. They must have normal preoperative kidney function and not be on dialysis, pregnant, nursing, allergic to PPIs, or have liver disease or vitamin B12 deficiency.

What is being tested?

The study tests if intravenous pantoprazole can improve kidney function and reduce AKI after heart surgery using cardiopulmonary bypass compared to famotidine. It also looks at the effect on major adverse kidney events.

What are the potential side effects?

Potential side effects may include digestive issues like nausea or stomach pain, headache, dizziness, rash or itching due to an allergic reaction. Long-term use might lead to vitamin B12 deficiency.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for heart surgery with a high risk of kidney injury.

Exclusion Criteria

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

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I need surgery urgently.

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I depend on dialysis for kidney function.

Select...

I have been diagnosed with interstitial nephritis.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after surgery for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Number of subjects with incidence of MAKE

Number of subjects with incidence of any-stage postoperative AKI

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT01801280

21%

Common cold

Noro virus infection

100%

80%

60%

40%

20%

Study treatment Arm

Mycophenolate Mofetil (MMF)

MMF + PAN

EC-MPS

EC-MPS + PAN

Awards & Highlights

Drug Has Already Been Approved

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

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pantoprazole groupExperimental Treatment1 Intervention

Pantoprazole (40 mg iv every 12 hours/q12H) for 2 days perioperatively (first dose after anesthesia induction and before surgical incision, second dose at chest closure, then followed by 2 doses daily (Q12hr dosing) on postoperative (POD) 1 for a total of 4 doses over 2 days. There will be no other modifications in patient care.

Group II: Famotidine GroupActive Control1 Intervention

Famotidine (20 mg iv q12H) for 2 days perioperatively (first dose after anesthesia induction and before surgical incision, second dose at chest closure, then followed by 2 doses daily (Q12hr dosing) on POD 1 for a total of 4 doses over 2 days. There will be no other modifications in patient care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pantoprazole

2014

Completed Phase 4

~1500

0 / 5Eligibility criteria met