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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Coronary Artery Bypass
Myocardial Ischemia
Myocardial Infarction
Coronary Artery Disease
Interventions Drug: Intravenous infusion of saline
Other: Intravenous glutamate infusion
Enrollment 865
Recruitment Details 4 patients, 2 in each group were excluded because of intraoperative exclusion criteria
Pre-assignment Details  
Arm/Group Title Intravenous Glutamate Saline Infusion
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 430 435
Completed 428 433
Not Completed 2 2
Reason Not Completed
Intraoperative exclusion criteria             1             1
Intraoperative exclusion criteria             1             1
Arm/Group Title Intravenous Glutamate Saline Infusion Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 428 433 861
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 428 participants 433 participants 861 participants
68  (9) 68  (9) 68  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 428 participants 433 participants 861 participants
Female
75
  17.5%
82
  18.9%
157
  18.2%
Male
353
  82.5%
351
  81.1%
704
  81.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 428 participants 433 participants 861 participants
428 433 861
1.Primary Outcome
Title Number of Participants With Perioperative Myocardial Infarction, Postoperative Heart Failure or Postoperative Mortality
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Glutamate Saline Infusion
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 428 433
Measure Type: Count of Participants
Unit of Measure: Participants
31
   7.2%
25
   5.8%
2.Secondary Outcome
Title Degree of Perioperative Myocardial Injury
Hide Description p-CK-MB postoperative day 1, p-troponin-T postoperative day 3
Time Frame perioperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Glutamate Saline Infusion
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 411 427
Median (Inter-Quartile Range)
Unit of Measure: µg/L
CK-MB day 1
14
(10 to 23)
14
(10 to 23)
Troponin-T day 3
0.27
(0.16 to 0.57)
0.24
(0.13 to 0.52)
3.Secondary Outcome
Title Postoperative Hemodynamic State
Hide Description Mixed venous oxygen saturation (SvO2) measured at weaning from cardiopulmonary bypass and on arrival to ICU
Time Frame Until arrival to ICU
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Glutamate Saline Infusion
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 416 421
Mean (Standard Deviation)
Unit of Measure: percentage of saturated hemoglobin
SvO2 at weaning from CPB 72.0  (7.6) 72.2  (7.3)
SvO2 on arrival to ICU 65.0  (7.0) 64.9  (6.9)
4.Secondary Outcome
Title Postoperative Hemodynamic State in Patients With Severely Reduced Left Ventricular Ejection Fraction (LVEF<0.40)
Hide Description 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)
Time Frame End of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Moderately or severely reduced LVEF (<0.40)
Arm/Group Title Intravenous Glutamate Saline Infusion
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 71 75
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.4%
5
   6.7%
5.Secondary Outcome
Title Postoperative Renal Function
Hide Description maximum p-creatinine value recorded postoperatively < 30 days
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Glutamate Saline Infusion
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 428 433
Mean (Standard Deviation)
Unit of Measure: µmol/L
106  (50) 106  (50)
6.Secondary Outcome
Title Number of Participants With Postoperative Stroke < 24 Hours
Hide Description Incidence of Postoperative stroke < 24 hours of surgery verifed by CT-scan
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Glutamate Saline Infusion
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 428 433
Measure Type: Count of Participants
Unit of Measure: Participants
4
   0.9%
6
   1.4%
7.Secondary Outcome
Title ICU Stay
Hide Description ICU duration of stay (hours)
Time Frame ICU stay
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Glutamate Saline Infusion
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 428 433
Median (Inter-Quartile Range)
Unit of Measure: hours
21
(17 to 23)
21
(17 to 23)
8.Secondary Outcome
Title Atrial Fibrillation
Hide Description Number of patients with atrial fibrillation recorded postoperatively
Time Frame Hospital stay
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous Glutamate Saline Infusion
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 428 433
Measure Type: Count of Participants
Unit of Measure: Participants
147
  34.3%
152
  35.1%
9.Secondary Outcome
Title Severe Circulatory Failure in CCS Class IV Patients
Hide Description Severe circulatory failure according to prespecified criteria as judged by a blinded endpoints committee in CCS class IV patients
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
CCS class IV patients
Arm/Group Title Intravenous Glutamate Saline Infusion
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 225 233
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.3%
16
   6.9%
10.Secondary Outcome
Title Long-term Survival
Hide Description Late mortality - related to biochemical markers (troponin-T, mixed venous oxygen saturation, NT-proBNP) and intervention
Time Frame 6 months - 10 years
Outcome Measure Data Not Reported
Time Frame 30 days or in hospital
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous Glutamate Saline Infusion
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Intravenous Glutamate Saline Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   4/428 (0.93%)   5/433 (1.15%) 
Hide Serious Adverse Events
Intravenous Glutamate Saline Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   54/428 (12.62%)   59/433 (13.63%) 
Blood and lymphatic system disorders     
Reoperation for bleeding  [1]  22/428 (5.14%)  21/433 (4.85%) 
Cardiac disorders     
Severe circulatory failure  [2]  10/428 (2.34%)  18/433 (4.16%) 
Perioperative myocardial infarction  [3]  11/428 (2.57%)  6/433 (1.39%) 
Cardiac mortality  [4]  1/428 (0.23%)  4/433 (0.92%) 
Infections and infestations     
Infection  [5]  4/428 (0.93%)  8/433 (1.85%) 
Nervous system disorders     
Stroke < 24 hours  [6]  4/428 (0.93%)  6/433 (1.39%) 
Renal and urinary disorders     
Postoperative dialysis  [7]  2/428 (0.47%)  6/433 (1.39%) 
Indicates events were collected by systematic assessment
[1]
Reoperation for bleeding during the postoperative course
[2]
Postoperative heart failure according to prespecified criteria
[3]
Troponin-T > 2.0 μg/L on the third or fourth postoperative day
[4]
Death within 30 days or in hospital due to cardiac cause as determined by a blinded end-point committee
[5]
Infection requiring surgery (mainly deep sternal wound infections)
[6]
Stroke within 24 hours of surgery
[7]
New onset dialysis postoperatively
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intravenous Glutamate Saline Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   164/428 (38.32%)   165/433 (38.11%) 
Cardiac disorders     
Postoperative atrial fibrillation * [1]  147/428 (34.35%)  152/433 (35.10%) 
Gastrointestinal disorders     
Postoperative nausea * [2]  139/428 (32.48%)  114/433 (26.33%) 
Infections and infestations     
Infection * [3]  33/428 (7.71%)  27/433 (6.24%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory * [4]  39/428 (9.11%)  45/433 (10.39%) 
Skin and subcutaneous tissue disorders     
Skin reaction * [5]  3/428 (0.70%)  7/433 (1.62%) 
*
Indicates events were collected by non-systematic assessment
[1]
Postoperative atrial fibrillation recorded in the institutional database
[2]
Postoperative nausea as reported by attending nurse
[3]
Postoperative infection not requiring surgery or extending hospital stay
[4]
Respiratory problems (atelectasis, pleural effusion, respiratory discomfort, need for oxygen etc) reported but not extending hospital stay
[5]
Rash, itching or other skin reaction reported by attending nurse
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rolf Svedjeholm
Organization: Dept Cardiothoracic Surgery, Linköping University Hospital, SE58185 Linköping, Sweden
Phone: +46101034825
EMail: rolf.svedjeholm@regionostergotland.se
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rolf Svedjeholm, 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 Submitted: June 19, 2007
First Posted: June 21, 2007
Results First Submitted: October 30, 2017
Results First Posted: June 7, 2019
Last Update Posted: September 16, 2020