| CTRI Number |
CTRI/2025/01/079208 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of administering Intralipid drug during the bypass in Patients Undergoing Off-Pump Coronary Artery Bypass Surgery |
|
Scientific Title of Study
|
Effect of Peri-conditioning with intralipid in Patients Undergoing Off-Pump Coronary Artery Bypass Surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gegal Pruthi |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anaesthesia, All India Institute of Medical Sciences Bathinda, Bathinda , Punjab.
Bathinda
Bathinda PUNJAB 151001 India |
| Phone |
8558038098 |
| Fax |
|
| Email |
drpkc12@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gegal Pruthi |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anaesthesia, All India Institute of Medical Sciences Bathinda, Bathinda , Punjab.
Bathinda
PUNJAB 151001 India |
| Phone |
8558038098 |
| Fax |
|
| Email |
drpkc12@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Gegal Pruthi |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anaesthesia, All India Institute of Medical Sciences Bathinda, Bathinda , Punjab.
Bathinda
PUNJAB 151001 India |
| Phone |
8558038098 |
| Fax |
|
| Email |
drpkc12@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bathinda, Punjab, India - 151001 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bathinda |
| Address |
All India Institute of Medical Sciences, Bathinda, Punjab, India - 151001. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gegal Pruthi |
All India Institute of Medical Sciences, Bathinda |
Room number 141, Department of Anaesthesia, All India Institute of Medical Sciences, Bathinda, Punjab. Bathinda PUNJAB |
8558038098
drpkc12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BATHINDA ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I21||Acute myocardial infarction, (2) ICD-10 Condition: I25||Chronic ischemic heart disease, (3) ICD-10 Condition: I20-I25||Ischemic heart diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intralipid Infusion |
Infusion of 20% Intralipid 2ml/kg from the start of Left Internal Mammary Artery harvesting till the end of grafting over a period of 90 minutes |
| Comparator Agent |
Normal Saline |
Normal saline 2 ml per kg from the start of Left Internal Mammary Artery harvesting till the end of grafting over a period of 90 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective Off Pump Coronary Artery Bypass Surgery (OPCAB) with left ventricular ejection fraction (LVEF) more than 40 percentage. |
|
| ExclusionCriteria |
| Details |
Combined valve and coronary surgery, on-pump CABG, redo cardiac surgery, hyperlipidaemia, significant hepatic or renal dysfunction, uncontrolled hypertension, diabetes mellitus, any disorder with immunological dysfunction (like malignancy or positive serological test for the HIV) in the last 6 months, preoperative treatment with nicorandil (an ATP-sensitive potassium channel opener), sulfonylurea (an ATP- sensitive potassium channel blocker). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the cardioprotective role of Intralipid (IL) by assessing Troponin I |
postoperatively 6th hourly, 24th hourly, 48th hourly and 72nd hourly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find out the hemodynamic effect of intralipid on systemic circulation |
intraoperatively initiating intralipid infusion at 0 min, 1 min, 5 min, 10 min, 15 min, 20min, 25 min, 30 min and postoperatively after shifting |
| to estimate the clinical effect of inotropic use |
intraoperatively, POD-1 and POD-2 |
| LVEF |
at the time of discharge |
| to find out the effect of intralipid on the serum levels of blood lipids, serum creatinine and total bilirubin |
pre-operatively, post-operatively POD1 and POD2 |
| to find out the effect of intralipid on the ventilatory hours and length of ICU stay post-operatively |
Post-operative period |
| to find out the outcome on the complications occuring during hospitalisation including arrhythmias, stroke, infection, respiratory failure, hepatic or renal failure, reoperation and mortality will be noted |
intraoperative and postoperative period |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/02/2025 |
| Date of Study Completion (India) |
20/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/03/2026 |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients satisfying the inclusion criteria will be divided into 2 groups based on closed envelope technique. Patients belonging to the interventional group will be considered as Group L and thoseserving as controls will be Group C. Baseline echocardiography, liver function tests, renal function tests, serum lipid profile, cTnI , ProBNP will be noted prior to surgery. Revascularisation will be done by a single surgeon and it usually takes 60 to 90 minutes for complete revascularisation (2 to 3 grafts) in our institute. Sixty two patients, scheduled to undergo elective OPCAB surgery, will be randomly assigned to the IL group (n = 31) or control (C) group (n = 31); the IL group will receive an infusion of 20% IL 2 ml/kg from the start of Left Internal Mammary Artery harvesting till the end of grafting over a period of 90 minutes, whereas the control group will receive an equivalent volume of normal saline. Hemodynamics will be continuously monitored during intralipid infusion. Serum levels of cTnI and NT ProBNP will be noted before surgery and at 6 h, 24 h, 48 h, and 72 h postoperatively. Also, intraoperative hemodynamic parameters, inotrope use, ventilatory hours, ICU stay, postoperative left ventricular ejection fraction, postoperative lipid profile, renal and hepatic function tests will be measured. Echocardiography, LFTs, RFTs will be monitored prior to surgery and also on POD1 and POD3. |