Phase 3
Completed N=865
Glutamate for Metabolic Intervention in Coronary Surgery
Source: ClinicalTrials.gov NCT00489827 ↗Enrolled (actual)
865
Serious AEs
13.1%
Results posted
Jun 2019
Primary outcomePrimary: Number of Participants With Perioperative Myocardial Infarction, Postoperative Heart Failure or Postoperative Mortality — 31; 25 Participants
◆ Published Evidence
Established
46citations · ~4 / year
EuroSCORE II and N-terminal pro-B-type natriuretic peptide for risk evaluation: an observational longitudinal study in patients undergoing coronary artery bypass graft surgery.
Summary
The main purpose of this study is to determine whether intravenous glutamate infusion given in association with surgery for unstable coronary artery disease can protect the heart from myocardial injury, postoperative heart failure and death.
Linked Publications (5)
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EuroSCORE II and N-terminal pro-B-type natriuretic peptide for risk evaluation: an observational longitudinal study in patients undergoing coronary artery bypass graft surgery.
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Association of Glutamate Infusion With Risk of Acute Kidney Injury After Coronary Artery Bypass Surgery: A Pooled Analysis of 2 Randomized Clinical Trials.
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Utility of NT-proBNP as an objective marker of postoperative heart failure after coronary artery bypass surgery: a prospective observational study.
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The impact of glutamate infusion on postoperative NT-proBNP in patients undergoing coronary artery bypass surgery: a randomized study.
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Post hoc analysis of the glutamics-trial: intravenous glutamate infusion and use of inotropic drugs after cabg.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Perioperative Myocardial Infarction, Postoperative Heart Failure or Postoperative Mortality |
31; 25 | — |
| SECONDARY Degree of Perioperative Myocardial Injury |
14; 14; 0.27; 0.24 | — |
| SECONDARY Postoperative Hemodynamic State |
72.0; 72.2; 65.0; 64.9 | — |
| SECONDARY Postoperative Hemodynamic State in Patients With Severely Reduced Left Ventricular Ejection Fraction (LVEF<0.40) |
1; 5 | — |
| SECONDARY Postoperative Renal Function |
106; 106 | — |
| SECONDARY Number of Participants With Postoperative Stroke < 24 Hours |
4; 6 | — |
| SECONDARY ICU Stay |
21; 21 | — |
| SECONDARY Atrial Fibrillation |
147; 152 | — |
| SECONDARY Severe Circulatory Failure in CCS Class IV Patients |
3; 16 | — |
| SECONDARY 10-year Survival |
301; 301 | — |
| SECONDARY Postoperative Mortality |
4; 5 | — |
Eligibility Criteria
Inclusion Criteria
- surgery for unstable coronary artery disease (unstable angina, non-STEMI)
- accepted for surgery 125 kg
- food allergy known to have caused flush, rash or asthma
Data sourced from ClinicalTrials.gov (NCT00489827) and the linked publication. 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. Informational only — not medical advice.