Trial Outcomes & Findings for Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF (NCT NCT04560309)
NCT ID: NCT04560309
Last Updated: 2023-11-13
Results Overview
Plasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
Before induction to anesthesia
Results posted on
2023-11-13
Participant Flow
Participants were recruited based on inclusion criteria. This study was carried out at National Cardiovascular Center Harapan Kita. Written informed consent was obtained from all eligible patients. This study was conducted from January to October 2021.
Sixty patients with a left ventricle EF of 31-50% who underwent on-pump CABG were included in this study and randomized to treatment. Two patients were dropped out in this study
Participant milestones
| Measure |
Glutamine
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Glutamine
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Overall Study
Meet drop out criteria
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.21 years
STANDARD_DEVIATION 7.29 • n=29 Participants
|
61.31 years
STANDARD_DEVIATION 6.48 • n=29 Participants
|
60.76 years
STANDARD_DEVIATION 6.85 • n=58 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=29 Participants
|
1 Participants
n=29 Participants
|
4 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=29 Participants
|
28 Participants
n=29 Participants
|
54 Participants
n=58 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
26.25 kg/m^2
STANDARD_DEVIATION 2.53 • n=29 Participants
|
26.47 kg/m^2
STANDARD_DEVIATION 2.85 • n=29 Participants
|
26.36 kg/m^2
STANDARD_DEVIATION 2.67 • n=58 Participants
|
|
Pre-op Ejection Fraction
|
41.44 percent
n=29 Participants
|
44.00 percent
n=29 Participants
|
43.00 percent
n=58 Participants
|
PRIMARY outcome
Timeframe: Before induction to anesthesiaPlasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Plasma Troponin I at Baseline
|
0.42 ng/mL
Interval 0.0 to 27.0
|
0.17 ng/mL
Interval 0.0 to 1.98
|
PRIMARY outcome
Timeframe: 5 minute after cardiopulmonary bypassPlasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Plasma Troponin I at 5 Minute After Cardiopulmonary Bypass
|
1.72 ng/mL
Standard Deviation 0.98
|
1.68 ng/mL
Standard Deviation 1.10
|
PRIMARY outcome
Timeframe: 6 hour after cardiopulmonary bypassPlasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Plasma Troponin I at 6 Hour After Cardiopulmonary Bypass
|
3.43 ng/mL
Standard Deviation 1.51
|
4.41 ng/mL
Standard Deviation 1.89
|
PRIMARY outcome
Timeframe: 24 hour after cardiopulmonary bypassPlasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Plasma Troponin I at 24 Hour After Cardiopulmonary Bypass
|
3.08 ng/mL
Interval 1.3 to 6.59
|
3.77 ng/mL
Interval 0.0 to 36.53
|
PRIMARY outcome
Timeframe: 48 hour after cardiopulmonary bypassPlasma troponin I were measured using enzyme immunoassay (ELISA) in unit of ng/mL
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Plasma Troponin I at 48 Hour After Cardiopulmonary Bypass
|
1.66 ng/mL
Interval 0.0 to 7.33
|
1.75 ng/mL
Interval 0.0 to 53.33
|
PRIMARY outcome
Timeframe: Before induction to anesthesiaPlasma glutamine were measured using colorimetric tests in unit of µmol/L
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Plasma Glutamine at Baseline
|
555.09 μmol/L
Standard Deviation 198.16
|
632.24 μmol/L
Standard Deviation 266.36
|
PRIMARY outcome
Timeframe: 24 hour after cardiopulmonary bypassPlasma glutamine were measured using colorimetric tests in unit of µmol/L
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Plasma Glutamine at 24 Hour After Cardiopulmonary Bypass
|
935.42 μmol/L
Standard Deviation 319.10
|
634.79 μmol/L
Standard Deviation 243.89
|
SECONDARY outcome
Timeframe: 5 minute after cardiopulmonary bypassRight atrial appendage alpha-ketoglutarate were measured from right atrial appendage tissue biopsy using colorimetric tests in unit of g/mol.
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Right Atrial Appendage Alpha-ketoglutarate
|
674.93 g/mol
Standard Deviation 333.49
|
507.32 g/mol
Standard Deviation 280.79
|
SECONDARY outcome
Timeframe: 5 minute after cardiopulmonary bypassRight atrial appendage myocardial injury score were measured from tissue section stained with hematoxylin-eosin and examined under by light microscopy in score of 0 (no change) to 3 (major changes with necrosis and diffuse inflammation). Higher scores mean worse outcome
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Right Atrial Appendage Myocardial Injury Score
|
1.30 score on a scale
Standard Deviation 0.24
|
1.48 score on a scale
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: 5 minute after cardiopulmonary bypassRight atrial appendage apoptosis index were measured from tissue section stained with in situ terminal deoxynucleotidyl transferase dUTP nick end labelling (TUNEL) and examined under light microscopy in average number of apoptotic cells (positively stained) from 6 random fields per section
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Right Atrial Appendage Apoptosis Index
|
5.00 cell
Interval 0.0 to 45.0
|
6.17 cell
Interval 1.0 to 52.0
|
SECONDARY outcome
Timeframe: 5 minute after cardiopulmonary bypassRight atrial appendage anti cardiac troponin I expression were measured from tissue section stained with anti-cardiac troponin I antibody and examined under light microscopy in score of 0 (no change) to -3 (no area observed with anti-cardiac troponin I expression). Higher score mean better outcome
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Anti Cardiac Troponin I Expression
|
-0.33 score on a scale
Interval -1.0 to 0.0
|
-0.83 score on a scale
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: Immediately after induction of anesthesiaEjection fraction were measured by transesophageal echocardiography using Simpson method in percentage (%)
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Ejection Fraction
|
41.40 percentage
Interval 30.7 to 47.5
|
41.60 percentage
Interval 32.0 to 49.6
|
SECONDARY outcome
Timeframe: 5 minutes after cardiopulmonary bypassEjection fraction were measured by transesophageal echocardiography using Simpson method in percentage (%)
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Ejection Fraction
|
46.17 percentage
Standard Deviation 5.15
|
45.55 percentage
Standard Deviation 5.03
|
SECONDARY outcome
Timeframe: Immediately after induction of anesthesia, 5 minute, 2 hour, 6 hour, 24 hour after cardiopulmonary bypassCardiac index were measured from pulmonary artery catheter using thermodilution method in unit of L/min/m\^2
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Cardiac Index
Immediately after induction of anesthesia
|
2.00 L/min/m^2
Standard Deviation 0.58
|
1.87 L/min/m^2
Standard Deviation 0.35
|
|
Cardiac Index
5 minutes after cardiopulmonary bypass
|
3.15 L/min/m^2
Standard Deviation 0.57
|
3.03 L/min/m^2
Standard Deviation 0.38
|
|
Cardiac Index
2 hours after cardiopulmonary bypass
|
2.45 L/min/m^2
Standard Deviation 0.55
|
2.36 L/min/m^2
Standard Deviation 0.56
|
|
Cardiac Index
6 hours after cardiopulmonary bypass
|
2.54 L/min/m^2
Standard Deviation 0.45
|
2.27 L/min/m^2
Standard Deviation 0.40
|
|
Cardiac Index
24 hours after cardiopulmonary bypass
|
2.68 L/min/m^2
Standard Deviation 0.35
|
2.47 L/min/m^2
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Before induction to anesthesiaPlasma lactate were measured using enzymatic method by blood gas analyser machine in unit of mmol/L
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Plasma Lactate Before Induction to Anesthesia
|
1.40 mmol/L
Interval 0.9 to 2.4
|
1.30 mmol/L
Interval 0.5 to 2.3
|
SECONDARY outcome
Timeframe: 5 minute after cardiopulmonary bypassPlasma lactate were measured using enzymatic method by blood gas analyser machine in unit of mmol/L
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Plasma Lactate 5 Minute After Cardiopulmonary Bypass
|
2.02 mmol/L
Standard Deviation 0.53
|
2.08 mmol/L
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: 6 hours after cardiopulmonary bypassPlasma lactate were measured using enzymatic method by blood gas analyser machine in unit of mmol/L
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Plasma Lactate 6 Hours After Cardiopulmonary Bypass
|
5.30 mmol/L
Interval 1.2 to 9.5
|
5.70 mmol/L
Interval 2.8 to 11.3
|
SECONDARY outcome
Timeframe: 24 hours after cardiopulmonary bypassPlasma lactate were measured using enzymatic method by blood gas analyser machine in unit of mmol/L
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Plasma Lactate 24 Hours After Cardiopulmonary Bypass
|
2.08 mmol/L
Standard Deviation 0.67
|
2.46 mmol/L
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: 48 hours after cardiopulmonary bypassPlasma lactate were measured using enzymatic method by blood gas analyser machine in unit of mmol/L
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Plasma Lactate 48 Hours After Cardiopulmonary Bypass
|
2.13 mmol/L
Standard Deviation 0.63
|
2.28 mmol/L
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: 28 days (or until hospital discharge)Intensive care unit ventilation time were measured from length of time participant was on ventilator in intensive care unit in minutes.
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Intensive Care Unit Ventilation Time
|
652.82 minutes
Standard Deviation 195.09
|
656.82 minutes
Standard Deviation 277.07
|
SECONDARY outcome
Timeframe: 28 days (or until hospital discharge)Intensive care unit length of stay were measured from length of time participant spent in intensive care unit in unit of hours
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Intensive Care Unit Length of Stay
|
20.00 hours
Interval 14.0 to 28.0
|
20.00 hours
Interval 16.0 to 29.0
|
SECONDARY outcome
Timeframe: 28 days (or until hospital discharge)Vasoactive inotropic score (VIS) were maximum vasoactive and inotropic dose required by participant after surgery measured by VIS=dopamine dose in mg/kgbw/min + dobutamine dose in mg/kgbw/min + 100 x epinephrine dose in mg/kgbw/min + 10 x milrinone dose in mcg/kgbw/min + 10.000 x vasopressin dose in units/kgbw/min + 100 x norepinephrine dose in mcg/kgbw/min. Higher scores means worse outcomes. VIS \>= 20 is considered as high VIS and is associated with poor outcomes.
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Vasoactive Inotropic Score
|
5.00 score on a scale
Interval 0.0 to 15.0
|
5.00 score on a scale
Interval 0.0 to 17.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraoperativeNumber of coronary arteries grafted during operation
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Coronary Graft
|
3.00 grafts
Interval 2.0 to 4.0
|
3.00 grafts
Interval 2.0 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraoperativeTotal time taken for the surgical procedure. Measured in minutes.
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Total Surgical Procedure Time
|
225.79 minutes
Standard Deviation 45.60
|
214.48 minutes
Standard Deviation 50.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraoperativeTotal time measured the patient went under cardiopulmonary bypass. Measured in minutes.
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Cardiopulmonary Bypass Time
|
87.00 minutes
Interval 55.0 to 113.0
|
78.00 minutes
Interval 39.0 to 138.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraoperativeTotal time the patient underwent aortic cross-clamping during the surgical procedure. Measured in minutes.
Outcome measures
| Measure |
Glutamine
n=29 Participants
Intravenous L-alanyl-L-glutamine 0.5 mg/kgbw
L-alanyl-L-glutamine dipeptide: Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
|
Control
n=29 Participants
Intravenous NaCl 0.9%
Placebo: Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
|
|---|---|---|
|
Aortic Cross-clamping Time
|
44.38 minutes
Standard Deviation 9.07
|
43.86 minutes
Standard Deviation 14.81
|
Adverse Events
Glutamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
I Made Adi Parmana, M.D.
Nationcal Cardiovascular Center Harapan Kita
Phone: +62 812-4601-212
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place