Effect of Peri-conditioning with intralipid in Patients Undergoing Off-Pump Coronary Artery Bypass Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- To evaluate the cardioprotective role of Intralipid (IL) by assessing Troponin I
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients posted for elective Off Pump Coronary Artery Bypass Surgery (OPCAB) with left ventricular ejection fraction (LVEF) more than 40 percentage.
排除标准
- •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).
结局指标
主要结局
To evaluate the cardioprotective role of Intralipid (IL) by assessing Troponin I
时间窗: postoperatively 6th hourly, 24th hourly, 48th hourly and 72nd hourly
次要结局
- 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)
研究者
Dr Gegal Pruthi
All India Institute of Medical Sciences, Bathinda