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Clinical trial

Phase III Study of Metabolic Intervention With Glutamate in Coronary Surgery II

ID
Name
EudraCT 2011-006241-15
Description
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.
Trial arms
Trial start
2015-11-15
Estimated PCD
2020-10-30
Trial end
2020-10-30
Status
Completed
Phase
Early phase I
Treatment
glutamate infusion
Intravenous infusion of 0.125M L-glutamic acid solution at a rate of 1.65 ml/kg BW and hour commencing at or up to 20 minutes before the release of aortic cross-clamp. The infusion is continued for two hours after declamping the aorta after which an additional 50 ml is given at a halved infusion rate.
Arms:
Intravenous glutamate infusion
Other names:
glutamate
saline infusion
Intravenous infusion of saline at a rate of 1.65 ml/kg BW and hour commencing at or up to 20 minutes before the release of aortic cross-clamp. The infusion is continued for two hours after declamping the aorta after which an additional 50 ml is given at a halved infusion rate.
Arms:
Intravenous saline infusion
Other names:
saline
Size
321
Primary endpoint
Postoperative Increase of Plasma 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 321, 'type': 'ACTUAL'}}
Updated at
2023-12-04

1 organization

2 products

3 indications

Organization
Linköping University Hospital
Product
Glutamate
Indication
coronary artery bypass surgery
Indication
Postoperative Complications
Indication
Congestive Heart Failure
Product
Saline