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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post operative day 7 (pod 7)(or hospital discharge if earlier)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post operative day 7 (pod 7)(or hospital discharge if earlier)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post operative day 7 (pod 7)(or hospital discharge if earlier)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post operative day 7 (pod 7)(or hospital discharge if earlier) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The area under the curve (AUC) of urinary kidney injury biomarkers Kidney Injury Molecule-1 (KIM-1) above baseline within 24 hours postoperatively

Secondary outcome measures

Number of subjects with incidence of MAKE

Number of subjects with incidence of any-stage postoperative AKI

The area under the curve (AUC) of Urinary Kidney Injury Biomarkers (Neutrophil gelatinase-associated lipocalin/NGAL, tissue inhibitor of metalloproteinases/TIMP-2, and insulin-like growth factor/IGFBP-7)

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,860 Total Patients Enrolled

1 Trials studying Acute Kidney Injury

415 Patients Enrolled for Acute Kidney Injury

Society of Cardiovascular AnesthesiologistsUNKNOWN

2 Previous Clinical Trials

5,542 Total Patients Enrolled

Yafen Liang, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass participants aged 70 or above?

"This study is for individuals aged 18 to 90. There are 144 trials that cater specifically towards those below the age of majority, and 686 involving patients above retirement age."

Answered by AI

To whom does this clinical investigation extend its eligibility?

"In order to participate in this medical trial, individuals must have acute kidney injury and fall within the age range of 18-90. 100 patients are being enrolled for observation purposes."

Answered by AI

Has the Treatment group been granted official authorization by the FDA?

"Treatment Group was rated highly in terms of safety, scoring a 3. The categorization as Phase 4 implies that it has already been approved by regulatory bodies."

Answered by AI

Is enrollment open for this trial at the present moment?

"Clinicaltrials.gov states that this medical trial, initially uploaded on December 1st 2023 and last modified 11/29/2023, is not presently seeking participants. However, 842 other trials are actively enrolling patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prevention of Post-Cardiac Surgery Acute Kidney Injury by Proton Pump Inhibitor

yafen liang 2024. "Prevention of Post-Cardiac Surgery Acute Kidney Injury by Proton Pump Inhibitor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06154226.

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