Glutamate for Metabolic Intervention in Coronary Surgery (GLUTAMICS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University Hospital Orebro
Blekingesjukhuset, Karlskrona
Information provided by (Responsible Party):
Rolf Svedjeholm, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT00489827
First received: June 19, 2007
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

The main purpose of this study is to determine whether intravenous glutamate infusion given in association with surgery for unstable coronary artery disease can protect the heart from myocardial injury, postoperative heart failure and death.


Condition Intervention Phase
Coronary Artery Bypass
Myocardial Ischemia
Myocardial Infarction
Coronary Artery Disease
Drug: Intravenous infusion of saline
Other: Intravenous glutamate infusion
Phase 3

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
Official Title: Phase III Study of Intravenous Glutamate Infusion for Metabolic Protection of the Heart in Surgery for Unstable Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Composite of perioperative myocardial infarction, postoperative heart failure or postoperative mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree of perioperative myocardial injury: CK-MB postoperative day 1, troponin-T postoperative day 3 [ Time Frame: perioperative ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Outcome and postoperative hemodynamic state in patients with severely reduced left ventricular ejection fraction (LVEF<0.40) [ Time Frame: End of surgery ] [ Designated as safety issue: No ]
  • Postoperative renal function: p-cystatin C (postoperative day 3) and maximal p-creatinine recorded [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Neurological safety issues: postoperative stroke (CT-scan) and p-S100B (substudy n=70) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • ICU treatment: duration of stay and ventilator treatment, dialysis, circulatory support (pharmacological / mechanical) [ Time Frame: ICU-stay ] [ Designated as safety issue: No ]
  • Atrial fibrillation [ Time Frame: Hospital stay ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Late mortality - related to biochemical markers (troponin-T, mixed venous oxygen saturation, NT-proBNP) and intervention [ Time Frame: 6 months - 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: October 2005
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous glutamate
Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Other: Intravenous glutamate infusion
Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Placebo Comparator: Saline infusion
Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Drug: Intravenous infusion of saline
Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.

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  Eligibility

Ages Eligible for Study:   up to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489827

Locations
Sweden
Blekingesjukhuset, Karlskrona
Karlskrona, Sweden, SE-371 85
University Hospital, Linkoeping
Linkoeping, Sweden, SE-581 85
University Hospital, Oerebro
Oerebro, Sweden, SE 701 85
Sponsors and Collaborators
University Hospital, Linkoeping
University Hospital Orebro
Blekingesjukhuset, Karlskrona
Investigators
Study Director: Rolf Svedjeholm, MD PhD University Hospital, Linkoeping
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rolf Svedjeholm, Professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT00489827     History of Changes
Other Study ID Numbers: 151:2003/70403, 20030595, M76-05
Study First Received: June 19, 2007
Last Updated: January 16, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by University Hospital, Linkoeping:
Coronary Artery Bypass
Myocardial Protection
Angina, Unstable
Myocardial Ischemia
Myocardial Infarction
Unstable Coronary Artery Disease
Glutamate

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Ischemia
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on April 16, 2014