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Glutamate for Metabolic Intervention in Coronary Surgery (GLUTAMICS)

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ClinicalTrials.gov Identifier: NCT00489827
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : June 7, 2019
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Region Örebro County
Blekingesjukhuset, Karlskrona
Information provided by (Responsible Party):
Rolf Svedjeholm, University Hospital, Linkoeping

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Bypass Myocardial Ischemia Myocardial Infarction Coronary Artery Disease Drug: Intravenous infusion of saline Other: Intravenous glutamate infusion Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 865 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.




Primary Outcome Measures :
  1. Number of Participants With Perioperative Myocardial Infarction, Postoperative Heart Failure or Postoperative Mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Degree of Perioperative Myocardial Injury [ Time Frame: perioperative ]
    p-CK-MB postoperative day 1, p-troponin-T postoperative day 3

  2. Postoperative Hemodynamic State [ Time Frame: Until arrival to ICU ]
    Mixed venous oxygen saturation (SvO2) measured at weaning from cardiopulmonary bypass and on arrival to ICU

  3. Postoperative Hemodynamic State in Patients With Severely Reduced Left Ventricular Ejection Fraction (LVEF<0.40) [ Time Frame: End of surgery ]
    Hemodynamic instability despite inotropes or need for IABP at the end of surgery in patients with severely reduced left ventricular ejection fraction (LVEF<0.40)

  4. Postoperative Renal Function [ Time Frame: 30 days ]
    maximum p-creatinine value recorded postoperatively < 30 days

  5. Number of Participants With Postoperative Stroke < 24 Hours [ Time Frame: 24 hours ]
    Incidence of Postoperative stroke < 24 hours of surgery verifed by CT-scan

  6. ICU Stay [ Time Frame: ICU stay ]
    ICU duration of stay (hours)

  7. Atrial Fibrillation [ Time Frame: Hospital stay ]
    Number of patients with atrial fibrillation recorded postoperatively

  8. Severe Circulatory Failure in CCS Class IV Patients [ Time Frame: 30 days ]
    Severe circulatory failure according to prespecified criteria as judged by a blinded endpoints committee in CCS class IV patients

  9. Long-term Survival [ Time Frame: 6 months - 10 years ]
    Late mortality - related to biochemical markers (troponin-T, mixed venous oxygen saturation, NT-proBNP) and intervention



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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489827


Locations
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Sweden
Blekingesjukhuset, Karlskrona
Karlskrona, Sweden, SE-371 85
University Hospital, Linköping
Linköping, Sweden, SE-581 85
University Hospital, Örebro
Örebro, Sweden, SE 701 85
Sponsors and Collaborators
University Hospital, Linkoeping
Region Örebro County
Blekingesjukhuset, Karlskrona
Investigators
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Study Director: Rolf Svedjeholm, MD PhD University Hospital, Linkoeping
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rolf Svedjeholm, Professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT00489827    
Other Study ID Numbers: 151:2003/70403
20030595 ( Registry Identifier: 151/2003/70403 Swedish Medical Product Agency) )
M76-05 ( Other Identifier: Regional Ethical Review Board in Linkoping )
First Posted: June 21, 2007    Key Record Dates
Results First Posted: June 7, 2019
Last Update Posted: September 16, 2020
Last Verified: August 2020
Keywords provided by Rolf Svedjeholm, University Hospital, Linkoeping:
Coronary Artery Bypass
Myocardial Protection
Angina, Unstable
Myocardial Ischemia
Myocardial Infarction
Unstable Coronary Artery Disease
Glutamate
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases