Glutamate for Metabolic Intervention in Coronary Surgery II
Condition: Coronary Artery Bypass Surgery; Postoperative Complications; Heart Failure
MeSH terms: Heart Failure; Postoperative Complications
Intervention: glutamate infusion; saline infusion
Intervention description: 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.; 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 321.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: glutamate, heart failure, coronary artery bypass surgery

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