Trial · NCT04560309
Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF
NCT04560309, Phase 3, Completed, National Cardiovascular Center Harapan Kita Hospital Indonesia; results first posted 2023-11-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF. Trials, record NCT04560309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04560309
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF
- NCT number
- NCT04560309
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 60 participants, actual
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Conditions
- Coronary Artery Bypass, Cardiopulmonary Bypass, Coronary Artery Disease
- Interventions
- L-alanyl-L-glutamine dipeptide, Placebo
- First posted
- 2020-09-23
- Last updated
- 2023-11-13
- Results first posted
- 2023-11-13
- Limitations and caveats
This study has some limitations. Limitations includes the sampling time of right atrial appendage tissue which was only at 5 minutes after CPB. Right atrial appendage tissue was used for apoptotic index assessment using TUNEL staining. Right atrial appendage tissue could not be sampled at 6 hours after CPB because sternal closure was performed prior to 6 hours.
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma Troponin I at Baseline | Before induction to anesthesia | Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL |
| Primary | Plasma Troponin I at 5 Minute After Cardiopulmonary Bypass | 5 minute after cardiopulmonary bypass | Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL |
| Primary | Plasma Troponin I at 6 Hour After Cardiopulmonary Bypass | 6 hour after cardiopulmonary bypass | Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL |
| Primary | Plasma Troponin I at 24 Hour After Cardiopulmonary Bypass | 24 hour after cardiopulmonary bypass | Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL |
| Primary | Plasma Troponin I at 48 Hour After Cardiopulmonary Bypass | 48 hour after cardiopulmonary bypass | Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL |
| Primary | Plasma Glutamine at Baseline | Before induction to anesthesia | Plasma glutamine were measured using colorimetric tests in unit of µmol/L |
| Primary | Plasma Glutamine at 24 Hour After Cardiopulmonary Bypass | 24 hour after cardiopulmonary bypass | Plasma glutamine were measured using colorimetric tests in unit of µmol/L |
| Secondary | Right Atrial Appendage Alpha-ketoglutarate | 5 minute after cardiopulmonary bypass | Right atrial appendage alpha-ketoglutarate were measured from right atrial appendage tissue biopsy using colorimetric tests in unit of g/mol. |
| Secondary | Right Atrial Appendage Myocardial Injury Score | 5 minute after cardiopulmonary bypass | Right atrial appendage myocardial injury score were measured from tissue section stained with hematoxylin-eosin and examined under by light microscopy in score of 0 (no change) to 3 (major changes with necrosis and diffuse inflammation). Higher scores mean worse outcome |
| Secondary | Right Atrial Appendage Apoptosis Index | 5 minute after cardiopulmonary bypass | Right atrial appendage apoptosis index were measured from tissue section stained with in situ terminal deoxynucleotidyl transferase dUTP nick end labelling (TUNEL) and examined under light microscopy in average number of apoptotic cells (positively stained) from 6 random fields per section |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasma Troponin I at Baseline | Before induction to anesthesia | ng/mL | MEDIAN | |
| PRIMARY | Plasma Troponin I at 5 Minute After Cardiopulmonary Bypass | 5 minute after cardiopulmonary bypass | ng/mL | MEAN | |
| PRIMARY | Plasma Troponin I at 6 Hour After Cardiopulmonary Bypass | 6 hour after cardiopulmonary bypass | ng/mL | MEAN | |
| PRIMARY | Plasma Troponin I at 24 Hour After Cardiopulmonary Bypass | 24 hour after cardiopulmonary bypass | ng/mL | MEDIAN | |
| PRIMARY | Plasma Troponin I at 48 Hour After Cardiopulmonary Bypass | 48 hour after cardiopulmonary bypass | ng/mL | MEDIAN | |
| PRIMARY | Plasma Glutamine at Baseline | Before induction to anesthesia | μmol/L | MEAN | |
| PRIMARY | Plasma Glutamine at 24 Hour After Cardiopulmonary Bypass | 24 hour after cardiopulmonary bypass | μmol/L | MEAN | |
| SECONDARY | Right Atrial Appendage Alpha-ketoglutarate | 5 minute after cardiopulmonary bypass | g/mol | MEAN | |
| SECONDARY | Right Atrial Appendage Myocardial Injury Score | 5 minute after cardiopulmonary bypass | score on a scale | MEAN | |
| SECONDARY | Right Atrial Appendage Apoptosis Index | 5 minute after cardiopulmonary bypass | cell | MEDIAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Plasma Troponin I at Baseline | Glutamine | 0.42 | Full Range 0.00 to 27.00 | ng/mL | |
| Plasma Troponin I at Baseline | Control | 0.17 | Full Range 0.00 to 1.98 | ng/mL | |
| Plasma Troponin I at 5 Minute After Cardiopulmonary Bypass | Glutamine | 1.72 | Standard Deviation 0.98 | ng/mL | |
| Plasma Troponin I at 5 Minute After Cardiopulmonary Bypass | Control | 1.68 | Standard Deviation 1.10 | ng/mL | |
| Plasma Troponin I at 6 Hour After Cardiopulmonary Bypass | Glutamine | 3.43 | Standard Deviation 1.51 | ng/mL | |
| Plasma Troponin I at 6 Hour After Cardiopulmonary Bypass | Control | 4.41 | Standard Deviation 1.89 | ng/mL | |
| Plasma Troponin I at 24 Hour After Cardiopulmonary Bypass | Glutamine | 3.08 | Full Range 1.30 to 6.59 | ng/mL | |
| Plasma Troponin I at 24 Hour After Cardiopulmonary Bypass | Control | 3.77 | Full Range 0.00 to 36.53 | ng/mL | |
| Plasma Troponin I at 48 Hour After Cardiopulmonary Bypass | Glutamine | 1.66 | Full Range 0.00 to 7.33 | ng/mL | |
| Plasma Troponin I at 48 Hour After Cardiopulmonary Bypass | Control | 1.75 | Full Range 0.00 to 53.33 | ng/mL |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glutamine | 30 | |
| Overall Study | STARTED | Control | 30 | |
| Overall Study | COMPLETED | Glutamine | 29 | |
| Overall Study | COMPLETED | Control | 29 | |
| Overall Study | NOT COMPLETED | Glutamine | 1 | |
| Overall Study | NOT COMPLETED | Control | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Glutamine | 0 | 30 |
| Total, all-cause mortality | Control | 0 | 30 |
| Total, other adverse events | Glutamine | 0 | 30 |
| Total, other adverse events | Control | 0 | 30 |
| Total, serious adverse events | Glutamine | 0 | 30 |
| Total, serious adverse events | Control | 0 | 30 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Glutamine vs Control: deaths from any cause | Trial comparisons |
| Glutamine vs Control: 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/NCT04560309
GET https://conductscience.org/api/trials/v1/NCT04560309/registered?page=2