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

NCT06154226 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HSC-MS-22-0502
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether perioperative intravenous administration of pantoprazole will improve kidney function parameters following cardiac surgery with cardiopulmonary bypass compared to famotidine and to determine whether perioperative intravenous administration of pantoprazole will decrease the incidence of postoperative Acte Kidney Injury (AKI) and major adverse kidney events (MAKE).

Conditions

Acute Kidney Injury

Keywords

cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Kidney Injury Molecule-1 (KIM-1) Above Baseline Within 24 Hours Postoperatively

  The area under the curve (AUC) is a summary measure of the concentration of the biomarker over time and is expressed as (ng\*h/mL).

  from baseline (time 0) to 24 hours postoperatively

Secondary Outcomes (5)

• Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Neutrophil Gelatinase-associated Lipocalin (NGAL) Above Baseline Within 24 Hours Postoperatively

  from baseline (time 0) to 24 hours postoperatively

• Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Tissue Inhibitor of Metalloproteinases 2 (TIMP-2) Above Baseline Within 24 Hours Postoperatively

  from baseline (time 0) to 24 hours postoperatively

• Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Insulin-like Growth Factor-binding Protein 7 (IGFBP-7) Above Baseline Within 24 Hours Postoperatively

  from baseline (time 0) to 24 hours postoperatively

• Number of Participants With Any-stage Postoperative Acute Kidney Injury (AKI)

  from baseline to postoperative day 7 (or hospital discharge if earlier)

• Number of Participants With Major Adverse Kidney Events (MAKE)

  from baseline to 30 days after surgery

Study Arms (2)

Pantoprazole

EXPERIMENTAL

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.

Drug: Pantoprazole

Famotidine

ACTIVE COMPARATOR

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.

Drug: Famotidine

Interventions

Pantoprazole DRUG

Subjects will receive pantoprazole (40 mg iv q12H) for 2 days perioperatively \[first dose after anesthesia induction and before surgical incision, second dose at chest closure, then followed by 2 doses daily (Q12hr dosing) on post operative day 1 (POD 1) for a total of 4 doses over 2 days\].

Pantoprazole

Famotidine DRUG

Subjects will receive famotidine (20 mg iv q12H) for 2 days perioperatively \[first dose after anesthesia induction and before surgical incision, second dose at chest closure, then followed by 2 doses daily (Q12hr dosing) on POD 1 for a total of 4 doses over 2 days\].

Famotidine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for elective cardiac surgery with cardio pulmonary bypass (CPB) with a moderate to high risk of developing AKI (Cleveland risk score equal or higher than 3)

You may not qualify if:

• Preoperative eGFR\<30 ml/min per 1.73 m2
• Dialysis dependence
• Emergency surgery
• Pregnancy
• Nursing Patients
• Interstitial nephritis
• Proton pump inhibitors (PPIs) hypersensitivity
• Liver disease
• Vitamin B12 deficiency

Sponsors & Collaborators

• Society of Cardiovascular Anesthesiologists: collaborator
• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Pantoprazole; Famotidine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Azoles

Limitations and Caveats

The AUC values have low sensitivity for detecting differences between arms as a result of limited timepoints.

Results Point of Contact

• Title: Yafen Liang, MD
• Organization: The University of Texas Health Science Center at Houston

Yafen.Liang@uth.tmc.edu

(713) 500-6229

Study Officials

• Yafen Liang, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor who tests the urinary kidney injury biomarkers is blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 4, 2023
• Study Start: January 10, 2024
• Primary Completion: September 17, 2024
• Study Completion: October 10, 2024
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)