Trial · NCT06154226
Prevention of Post-Cardiac Surgery Acute Kidney Injury by Proton Pump Inhibitor
NCT06154226, Phase 2, Completed, The University of Texas Health Science Center, Houston; results first posted 2026-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prevention of Post-Cardiac Surgery Acute Kidney Injury by Proton Pump Inhibitor. Trials, record NCT06154226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06154226
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prevention of Post-Cardiac Surgery Acute Kidney Injury by Proton Pump Inhibitor
- NCT number
- NCT06154226
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Acute Kidney Injury
- Interventions
- Pantoprazole, Famotidine
- First posted
- 2023-12-04
- Last updated
- 2026-03-10
- Results first posted
- 2026-03-10
- Limitations and caveats
- The AUC values have low sensitivity for detecting differences between arms as a result of limited timepoints.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Kidney Injury Molecule-1 (KIM-1) Above Baseline Within 24 Hours Postoperatively | from baseline (time 0) to 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). |
| Secondary | 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 | 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). |
| Secondary | 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 | 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). |
| 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 | from baseline (time 0) to 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). |
| Secondary | Number of Participants With Any-stage Postoperative Acute Kidney Injury (AKI) | from baseline to postoperative day 7 (or hospital discharge if earlier) | 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. |
| Secondary | Number of Participants With Major Adverse Kidney Events (MAKE) | from baseline to 30 days after surgery | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Kidney Injury Molecule-1 (KIM-1) Above Baseline Within 24 Hours Postoperatively | from baseline (time 0) to 24 hours postoperatively | 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. | ng*h/mL | MEDIAN |
| SECONDARY | 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 | 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. | ng*h/mL | MEDIAN |
| SECONDARY | 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 | 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. | ng*h/mL | MEDIAN |
| 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 | from baseline (time 0) to 24 hours postoperatively | 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. | ng*h/mL | MEDIAN |
| SECONDARY | Number of Participants With Any-stage Postoperative Acute Kidney Injury (AKI) | from baseline to postoperative day 7 (or hospital discharge if earlier) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Major Adverse Kidney Events (MAKE) | from baseline to 30 days after surgery | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Kidney Injury Molecule-1 (KIM-1) Above Baseline Within 24 Hours Postoperatively | Famotidine Group | 51.4 | Inter-Quartile Range 39.1 to 66.8 | ng*h/mL | |
| Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Kidney Injury Molecule-1 (KIM-1) Above Baseline Within 24 Hours Postoperatively | Pantoprazole Group | 52.3 | Inter-Quartile Range 38.9 to 67.7 | ng*h/mL | |
| Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Neutrophil Gelatinase-associated Lipocalin (NGAL) Above Baseline Within 24 Hours Postoperatively | Famotidine Group | 2962 | Inter-Quartile Range 1692 to 4743 | ng*h/mL | |
| Area Under the Curve (AUC) of Urinary Kidney Injury Biomarker Neutrophil Gelatinase-associated Lipocalin (NGAL) Above Baseline Within 24 Hours Postoperatively | Pantoprazole Group | 3013 | Inter-Quartile Range 1650 to 5017 | ng*h/mL | |
| Number of Participants With Any-stage Postoperative Acute Kidney Injury (AKI) | Famotidine Group | 26 | Participants | ||
| Number of Participants With Any-stage Postoperative Acute Kidney Injury (AKI) | Pantoprazole Group | 19 | Participants | ||
| Number of Participants With Major Adverse Kidney Events (MAKE) | Famotidine Group | 3 | Participants | ||
| Number of Participants With Major Adverse Kidney Events (MAKE) | Pantoprazole Group | 1 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Famotidine Group | 50 | |
| Overall Study | STARTED | Pantoprazole Group | 50 | |
| Overall Study | COMPLETED | Famotidine Group | 50 | |
| Overall Study | COMPLETED | Pantoprazole Group | 50 | |
| Overall Study | NOT COMPLETED | Famotidine Group | 0 | |
| Overall Study | NOT COMPLETED | Pantoprazole Group | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrointestinal bleeding | Gastrointestinal disorders | Famotidine Group | 2 | 50 | |
| other | Gastrointestinal bleeding | Gastrointestinal disorders | Pantoprazole Group | 2 | 50 | |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | Famotidine Group | 3 | 50 | |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | Pantoprazole Group | 2 | 50 | |
| other | Acute interstitial nephritis | Renal and urinary disorders | Famotidine Group | 0 | 50 | |
| other | Acute interstitial nephritis | Renal and urinary disorders | Pantoprazole Group | 1 | 50 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Famotidine Group | 1 | 50 |
| Total, all-cause mortality | Pantoprazole Group | 1 | 50 |
| Total, other adverse events | Famotidine Group | 3 | 50 |
| Total, other adverse events | Pantoprazole Group | 5 | 50 |
| Total, serious adverse events | Famotidine Group | 0 | 50 |
| Total, serious adverse events | Pantoprazole Group | 0 | 50 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Famotidine Group vs Pantoprazole Group: Number of Participants With Major Adverse Kidney Events (MAKE) | Trial comparisons |
| Famotidine Group vs Pantoprazole Group: deaths from any cause | Trial comparisons |
| Famotidine Group vs Pantoprazole Group: Number of Participants With Any-stage Postoperative Acute Kidney Injury (AKI) | Trial comparisons |
| Famotidine Group vs Pantoprazole Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06154226
GET https://conductscience.org/api/trials/v1/NCT06154226/registered