Efficacy of Remote Ischemic Preconditioning on Diastolic Function in Coronary Artery Bypass Surgery: a Randomized Controlled Study Comparing Diabetic and Non-Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- E/e' Ratio (Diastolic Function)
研究概览
简要总结
This randomized controlled study aims to evaluate the effects of Remote Ischemic Preconditioning (RIPC) on diastolic function in patients undergoing coronary artery bypass grafting (CABG). The study will compare diabetic and non-diabetic patients to determine whether RIPC improves myocardial relaxation and reduces diastolic dysfunction, as assessed by the E/e' ratio at multiple time points during the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients scheduled for elective isolated on-pump CABG surgery for two- to three-vessel coronary artery disease.
- •Both males and females will be included.
- •In the diabetic groups: Type II diabetes currently requiring and adhering to insulin therapy for at least the past 3 months
- •During cardiopulmonary bypass, the temperature will range from 28-33°C using an esophageal temperature probe.
- •Antegrade warm cardioplegia will be given by the cardiovascular perfusionist.
- •Baseline diastolic function will be obtained preoperatively using transthoracic echocardiography done within the six months prior to the surgery
排除标准
- •Combined CABG and valve surgery, emergency CABG.
- •Type I diabetes, Type 2 diabetes managed with oral hypoglycemic agents without insulin in the past 3 months
- •Peripheral vascular disease (PVD) affecting the upper limbs.
- •Acute coronary syndrome (ACS); acute or recent myocardial infarction.
- •Left ventricular ejection fraction ≤30%.
- •Serious pulmonary disease necessitating oxygen supplementation or mechanical ventilation.
- •Renal failure, defined as eGFR < 30 mL/min/1.73 m² or requiring renal replacement therapy (dialysis).
- •Liver failure, including Child-Pugh Class B or C cirrhosis, severe hepatocellular dysfunction, or listed for liver transplantation.
研究组 & 干预措施
Diabetic with Remote ischemic preconditioning
Remote Ischemic Preconditioning (RIPC) Patients will undergo Remote Ischemic Preconditioning using a blood pressure cuff inflated on the upper limb to induce ischemia and reperfusion, 40 mmHg above systolic pressure. The procedure will involve 3 cycles of inflation (5 minutes each) and deflation (5 minutes each) post intubation.
干预措施: Remote ischemic preconditioning (Behavioral)
Non diabetic with Remote ischemic preconditioning
Remote Ischemic Preconditioning (RIPC) Non-diabetic patients who undergo Remote ischemic preconditioning using the same ischemia/reperfusion protocol as the diabetic group.
干预措施: Remote ischemic preconditioning (Behavioral)
Diabetic without Remote ischemic preconditioning
Diabetic patients who receive standard care for CABG surgery without Remote ischemic preconditioning
Non diabetic without Remote ischemic preconditioning
Non-diabetic patients who receive standard care for CABG surgery without RIPC.
结局指标
主要结局
E/e' Ratio (Diastolic Function)
时间窗: T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU
Echocardiography (Tissue Doppler Imaging) will be used to measure the E/e' ratio, a reliable parameter for assessing left ventricular filling pressure and diastolic function. This is the primary method to evaluate the effect of Remote Ischemic Preconditioning (RIPC) on diastolic function in both diabetic and non-diabetic patients undergoing CABG.
次要结局
- Mitral Inflow Velocities(E/A Ratio)(T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU)
- Deceleration Time (DT)(T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU)
- Cardiac Troponin Levels(Evaluate cardiac troponin levels postoperatively after 24 hours as a marker of myocardial injury)
- LVEF(Compare between start and end of surgery)
- Systolic and diastolic Blood pressure(T1: immediately after anesthesia induction and intubation (baseline) T2: Immediately before cardiopulmonary bypass (CPB) T3: 10 minutes after reperfusion and separation from CPB T4: 45 minutes after separation from CPB and before transfer to the ICU)
- Inotropic Support:(During surgery)
研究者
Alzahraa Khalil Marie
Assistant lecturer in Cairo university
Cairo University