Glutamate for Metabolic Intervention in Coronary Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 21 January 2013
• Main ID: NCT00489827
• Date of registration: 19/06/2007
• Primary sponsor: University Hospital, Linkoeping
• Public title: Glutamate for Metabolic Intervention in Coronary Surgery GLUTAMICS
• Scientific title: Phase III Study of Intravenous Glutamate Infusion for Metabolic Protection of the Heart in Surgery for Unstable Coronary Artery Disease
• Date of first enrolment: October 2005
• Target sample size: 800
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00489827
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

Sweden

Contacts

• Name: Rolf Svedjeholm, MD PhD
• Affiliation: University Hospital, Linkoeping

Key inclusion & exclusion criteria

Inclusion Criteria:

- surgery for unstable coronary artery disease (unstable angina, non-STEMI)

- accepted for surgery < 2 weeks after STEMI

- coronary surgery for indications above performed with or without cardiopulmonary
bypass

- coronary surgery for indications above with or without simultaneous valve procedure

Exclusion Criteria:

- informed consent not possible because of critical condition or other reason

- preoperative use of inotropes or mechanical circulatory assist

- preoperative dialysis

- redo-procedure

- unexpected intraoperative finding / event that increased the dignity of the procedure
to overshadow the originally planned operation

- body weight > 125 kg

- food allergy known to have caused flush, rash or asthma



Age minimum: N/A
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Artery Bypass

Coronary Artery Disease

Myocardial Infarction

Myocardial Ischemia

Intervention(s)

Drug: Intravenous infusion of saline

Other: Intravenous glutamate infusion

Primary Outcome(s)

Composite of perioperative myocardial infarction, postoperative heart failure or postoperative mortality [Time Frame: 30 days]

Secondary Outcome(s)

Atrial fibrillation [Time Frame: Hospital stay]

Degree of perioperative myocardial injury: CK-MB postoperative day 1, troponin-T postoperative day 3 [Time Frame: perioperative]

ICU treatment: duration of stay and ventilator treatment, dialysis, circulatory support (pharmacological / mechanical) [Time Frame: ICU-stay]

Late mortality - related to biochemical markers (troponin-T, mixed venous oxygen saturation, NT-proBNP) and intervention [Time Frame: 6 months - 5 years]

Neurological safety issues: postoperative stroke (CT-scan) and p-S100B (substudy n=70) [Time Frame: 24 hours]

Outcome and postoperative hemodynamic state in patients with severely reduced left ventricular ejection fraction (LVEF<0.40) [Time Frame: End of surgery]

Planned subgroup analyses: Patients requiring emergency surgery/intravenous nitrates, Patients with severely reduced LV-function, Diabetics, type of myocardial protection, OPCAB/ONCAB, combined CABG-valve procedures [Time Frame: 30 days]

Postoperative hemodynamic state: Mixed venous oxygen saturation + p-lactate, heart rate, systolic AP, diastolic AP, Pulmonary diastolic AP, CVP (weaning-arrival ICU) and NT-proBNP (24hrs, 3 days) [Time Frame: Hours-3days]

Postoperative renal function: p-cystatin C (postoperative day 3) and maximal p-creatinine recorded [Time Frame: 30 days]

Secondary ID(s)

151:2003/70403

20030595

M76-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Blekingesjukhuset, Karlskrona

University Hospital Orebro