Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04560309
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2020-09-07
Brief Title:
Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF
Sponsor:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Organization:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Study Overview
Official Title:
Role of Glutamine as Myocardial Protector in Elective On-Pump Coronary Artery Bypass Graft Surgery With Low Ejection Fraction
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Coronary artery disease has the highest mortality rate worldwide and coronary artery bypass grafting CABG is the most common cardiac surgery performed in patients with coronary artery disease to revascularize the heart Despite of improvement in operation techniques cardioplegia cardiopulmonary bypass CPB myocardial injury related to on-pump CABG is still prominent In patient with low ejection fraction undergone on-pump CABG myocardial injury is related to worse outcome and prognosis during peri-operative and post-operative period On-pump CABG patients with low ejection fraction has increased up to four times higher post-operative in hospital mortality rate compared to patient with normal ejection fraction Administration of intravenous glutamine had been documented in reducing myocardial damage during cardiac surgery and previous studies indicated that glutamine can protect against myocardial injury by various mechanism during ischemia and reperfusion The purpose of this study to determine whether intravenous glutamine could prevent the decline of plasma glutamine level reduce myocardial damage improve hemodynamic profile and reduce morbidity of on-pump CABG in patients with low ejection fraction
Detailed Description:
The study was a double-blind randomized controlled trial to assess the role of glutamine as a myocardial protection during coronary artery bypass grafting under cardiopulmonary bypass in patients with left ventricle ejection fraction of 31-50 This study was approved by Institutional Review Board of National Cardiovascular Center Harapan Kita and informed consent was obtained before randomization for patient eligible for this study Allocation of participant to the treatment group was done by block randomization by staff who was not involved in the study The intervention drug was prepared by pharmacist who also was not involved in the study Glutamine solution was supplied as L-alanyl-L-glutamine dipeptide Dipeptiven 200 mgmL Fresenius Kabi Bad Homburg Germany and was prepared to contain 05grkgbw glutamine diluted in NaCl 09 to a final volume of 500 mL Placebo was supplied as 500 ml of NaCl 09 prepared in similar fashion and packaging as glutamine solution Principal investigator care provider outcome assessor and participant were blinded to the assigned group until after the end of the study
Baseline participant characteristics were collected before the intervention included age sex body weight body height body mass index and documented pre-operative left ventricle ejection fraction Coronary artery bypass grafting and cardiopulmonary bypass was done in concordance to standard operating procedure in National Cardiovascular Center Harapan Kita followed by transit time flow meter measurement to ensure quality of the graft Modifying factor of the study the investigators measured duration of surgery duration of cardiopulmonary bypass and duration of aortic cross clamp
The primary outcome of the study was plasma troponin I level The investigators anticipated plasma troponin I level difference of 20 with standard deviation of 004 ngmL and for statistical power of 80 and level of significance of 005 the required sample size was 245 participants per group As anticipation for participant drop out the investigators planned to recruit a total of 60 participants
Baseline participant characteristics were collected before the intervention included age sex body weight body height body mass index and documented pre-operative left ventricle ejection fraction Coronary artery bypass grafting and cardiopulmonary bypass was done in concordance to standard operating procedure in National Cardiovascular Center Harapan Kita followed by transit time flow meter measurement to ensure quality of the graft Modifying factor of the study the investigators measured duration of surgery duration of cardiopulmonary bypass and duration of aortic cross clamp
The primary outcome of the study was plasma troponin I level The investigators anticipated plasma troponin I level difference of 20 with standard deviation of 004 ngmL and for statistical power of 80 and level of significance of 005 the required sample size was 245 participants per group As anticipation for participant drop out the investigators planned to recruit a total of 60 participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LB0201VII466KEP059202 | OTHER | National Cardiovascular Center Harapan Kita Indonesia | None |