Glutamate for Metabolic Intervention in Coronary Surgery II

• Status: Completed
• Trial end date: 2020-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Linkoeping
• Collaborators: Blekinge County Council Hospital; Region Örebro County; Sahlgrenska University Hospital, Sweden; University Hospital, Umeå; Uppsala University Hospital, Sweden

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