Phase 2
N=100
Prevention of Post-Cardiac Surgery Acute Kidney Injury by Proton Pump Inhibitor
Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT06154226 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Kidney Injury Molecule-1 (KIM-1) Above Baseline Within 24 Hours Postoperatively — 51.4; 52.3 ng*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pantoprazole (Drug); Famotidine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Kidney Injury Molecule-1 (KIM-1) Above Baseline Within 24 Hours Postoperatively |
51.4; 52.3 | — |
| SECONDARY Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Neutrophil Gelatinase-associated Lipocalin (NGAL) Above Baseline Within 24 Hours Postoperatively |
2962; 3013 | — |
| SECONDARY Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Tissue Inhibitor of Metalloproteinases 2 (TIMP-2) Above Baseline Within 24 Hours Postoperatively |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Number of Participants With Any-stage Postoperative Acute Kidney Injury (AKI) |
26; 19 | — |
| SECONDARY Number of Participants With Major Adverse Kidney Events (MAKE) |
3; 1 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06154226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.