Trial Outcomes & Findings for Prevention of Post-Cardiac Surgery Acute Kidney Injury by Proton Pump Inhibitor (NCT NCT06154226)
NCT ID: NCT06154226
Last Updated: 2026-03-10
Results Overview
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).
COMPLETED
PHASE2
100 participants
from baseline (time 0) to 24 hours postoperatively
2026-03-10
Participant Flow
All 100 participants completed the study; however, upon further verification before analysis, 2 participants who completed (1 per arm) were deemed to not meet the inclusion criteria; therefore, these 2 participants (1 per arm) were excluded from the analysis.
Participant milestones
| Measure |
Famotidine Group
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.
Famotidine: 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.
|
Pantoprazole Group
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.
Pantoprazole: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Famotidine Group
n=49 Participants
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.
Famotidine: 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.
|
Pantoprazole Group
n=49 Participants
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.
Pantoprazole: 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.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=49 Participants
|
65 years
n=49 Participants
|
65 years
n=98 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=49 Participants
|
18 Participants
n=49 Participants
|
39 Participants
n=98 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=49 Participants
|
31 Participants
n=49 Participants
|
59 Participants
n=98 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
49 participants
n=49 Participants
|
49 participants
n=49 Participants
|
98 participants
n=98 Participants
|
PRIMARY outcome
Timeframe: from baseline (time 0) to 24 hours postoperativelyPopulation: All 100 participants completed the study; however, upon further verification before analysis, 2 participants who completed (1 per arm) were deemed to not meet the inclusion criteria; therefore, these 2 participants (1 per arm) were excluded from the analysis. An intent-to-treat analysis is reported.
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).
Outcome measures
| Measure |
Famotidine Group
n=49 Participants
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.
Famotidine: 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.
|
Pantoprazole Group
n=49 Participants
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.
Pantoprazole: 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.
|
|---|---|---|
|
Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Kidney Injury Molecule-1 (KIM-1) Above Baseline Within 24 Hours Postoperatively
|
51.4 ng*h/mL
Interval 39.1 to 66.8
|
52.3 ng*h/mL
Interval 38.9 to 67.7
|
SECONDARY outcome
Timeframe: from baseline (time 0) to 24 hours postoperativelyPopulation: All 100 participants completed the study; however, upon further verification before analysis, 2 participants who completed (1 per arm) were deemed to not meet the inclusion criteria; therefore, these 2 participants (1 per arm) were excluded from the analysis. An intent-to-treat analysis is reported.
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).
Outcome measures
| Measure |
Famotidine Group
n=49 Participants
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.
Famotidine: 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.
|
Pantoprazole Group
n=49 Participants
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.
Pantoprazole: 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.
|
|---|---|---|
|
Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Neutrophil Gelatinase-associated Lipocalin (NGAL) Above Baseline Within 24 Hours Postoperatively
|
2962 ng*h/mL
Interval 1692.0 to 4743.0
|
3013 ng*h/mL
Interval 1650.0 to 5017.0
|
SECONDARY outcome
Timeframe: from baseline (time 0) to 24 hours postoperativelyPopulation: Data for the biomarker TIMP-2 were not collected. This is because in a prior non-interventional validation study, IGFBP-7 could not be validated with ELISA, and because a combination of TIMP-2 and IGFBP-7 are used to predict AKI risk, it was determined that TIMP-2 (which depends on IGFBP-7) will not be used used to predict AKI risk in this trial. The Study Protocol was not amended to reflect this collective team decision. Data collection and analysis will not be conducted in the future.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline (time 0) to 24 hours postoperativelyPopulation: Data for the biomarker IGFBP-7 were not collected. This is because in a prior non-interventional validation study, IGFBP-7 could not be validated with ELISA; therefore, it was determined that the IGFBP-7 biomarker will not be used used to predict AKI risk in this trial. The Study Protocol was not amended to reflect this collective team decision. Data collection and analysis will not be conducted in the future.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to postoperative day 7 (or hospital discharge if earlier)Population: All 100 participants completed the study; however, upon further verification before analysis, 2 participants who completed (1 per arm) were deemed to not meet the inclusion criteria; therefore, these 2 participants (1 per arm) were excluded from the analysis. An intent-to-treat analysis is reported.
Acute kidney injury (AKI) will be defined using the 2012 Kidney Disease Improving Global Outcomes (KDIGO) criteria: serum creatinine (SCr) increase greater than 50% from baseline or ≥ 0.3 mg/dL increase within 48 hours after surgery.
Outcome measures
| Measure |
Famotidine Group
n=49 Participants
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.
Famotidine: 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.
|
Pantoprazole Group
n=49 Participants
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.
Pantoprazole: 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.
|
|---|---|---|
|
Number of Participants With Any-stage Postoperative Acute Kidney Injury (AKI)
|
26 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: from baseline to 30 days after surgeryPopulation: All 100 participants completed the study; however, upon further verification before analysis, 2 participants who completed (1 per arm) were deemed to not meet the inclusion criteria; therefore, these 2 participants (1 per arm) were excluded from the analysis. An intent-to-treat analysis is reported.
MAKE is defined as the composite of death, dialysis, renal hospitalization or sustained kidney dysfunction defined as glomerular filtration rate (GFR) decline of 25% or more from preoperative baseline.
Outcome measures
| Measure |
Famotidine Group
n=49 Participants
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.
Famotidine: 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.
|
Pantoprazole Group
n=49 Participants
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.
Pantoprazole: 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.
|
|---|---|---|
|
Number of Participants With Major Adverse Kidney Events (MAKE)
|
3 Participants
|
1 Participants
|
Adverse Events
Famotidine Group
Pantoprazole Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Famotidine Group
n=50 participants at risk
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.
Famotidine: 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.
|
Pantoprazole Group
n=50 participants at risk
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.
Pantoprazole: 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.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
4.0%
2/50 • 30 days
|
4.0%
2/50 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.0%
3/50 • 30 days
|
4.0%
2/50 • 30 days
|
|
Renal and urinary disorders
Acute interstitial nephritis
|
0.00%
0/50 • 30 days
|
2.0%
1/50 • 30 days
|
Additional Information
Yafen Liang, MD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place