Phase 3
N=314
Glutamate for Metabolic Intervention in Coronary Surgery II
Coronary Artery Bypass Surgery · Postoperative Complications · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02592824 ↗Enrolled (actual)
314
Serious AEs
47.5%
Results posted
Dec 2023
Primary outcome: Primary: Postoperative Increase of Plasma NT-proBNP — 5390; 6452 ng/L — p=0.086
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- glutamate infusion (Drug); saline infusion (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- University Hospital, Linkoeping
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Increase of Plasma NT-proBNP |
5390; 6452 | 0.086 |
| SECONDARY Postoperative Plasma Level of NT-proBNP |
8055; 8804 | 0.36 |
| SECONDARY Postoperative Plasma Level of NT-proBNP |
8055; 8804 | 0.36 |
| SECONDARY Number of Participants With Incidence of Stroke |
0; 4 | — |
| SECONDARY Incidence of Mortality |
1; 6 | — |
| SECONDARY Incidence of Unexpected Adverse Events |
0; 0 | — |
Summary
The aim of GLUTAMICS II is to evaluate whether intravenous glutamate infusion surgery reduces the risk of postoperative heart failure as measured by plasma NT-proBNP in patients undergoing moderate to high-risk coronary artery bypass graft surgery. Patients accepted for coronary artery bypass surgery of at least two vessel disease or left main stenosis with or without concomitant procedure and considered to be at moderate to high surgical risk preoperatively with regard to postoperative heart failure will be studied. The primary endpoint is postoperative increase of NT-proBNP from the day before surgery to the third postoperative day.
Eligibility Criteria
Inclusion Criteria
Patients accepted for coronary artery bypass surgery of at least two vessel disease or left main stenosis with or without concomitant procedure considered to be at moderate to high surgical risk preoperatively with regard to postoperative heart failure due to:
- EuroSCORE II ≥ 3.0 with at least one of the following cardiac or procedure related risk factors:
- LVEF ≤ 0.50
- CCS class IV
- Recent Myocardial Infarct (≤ 90 days)
- Emergency / Urgent procedure (as defined in EuroSCORE II)
- CABG with aortic or mitral valve procedure
OR
- LVEF ≤ 0.30 regardless of EuroSCORE II
Exclusion Criteria
- age > 85 years
- ambiguous food allergies that trigger shortness of breath, headache or flushing
- previous cardiac surgery
- patients who are in such bad condition that they cannot be asked to participate
- patients who because of linguistic or other reasons are unable to provide informed consent
- severe renal failure with preoperative dialysis or calculated GFR <30 mL / min
- patients requiring mechanical circulatory support (intra-aortic balloon pump) due to circulatory failure before they are enrolled in the study
- surgery without heart-lung machine (off-pump)
- concomitant Maze-procedure
- surgery of ascending aorta
- surgery of both aortic and mitral valve
Data sourced from ClinicalTrials.gov (NCT02592824). 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.