Effect of Remote Ischemic Preconditioning on Serum Lactate Levels As Well As Cardiac and Renal Functions During and After Open Heart Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Serum lactate level
研究概览
简要总结
The objective of study is to detect effect of remote ischemic preconditioning on serum lactate levels during and after cardiac surgery with cardiopulmonary bypass in addition to its effect on cardiac and renal clinical outcomes.
详细描述
Remote ischemic preconditioning (RIPC) is a phenomenon where transient non-injurious ischemia/ reperfusion episodes applied to an organ away from the heart can protect the myocardium from ischemia/reperfusion injury. RIPC has been found to be an attractive strategy to reduce myocardial injury and improve outcome in patients undergoing cardiac surgery. The exact mechanisms of this protection are not yet known, although stimulation of prosurvival intracellular kinase responses and inhibition of inflammatory pathways each play a role.
RIPC can be performed by noninvasive inflation and deflation of a standard blood pressure cuff or pneumatic tourniquet on the upper or lower limbs to induce brief ischemia and reperfusion, which is the mechanism by which injury in patients undergoing open cardiac surgery occurs.
ANESTHETIC TECHNIQUE All patients will be preoperatively examined and investigated by complete blood count, coagulation profile, renal and kidney functions and electrolytes. Electrocardiography, chest x ray and echocardiography will be routinely done. Coronary angiography and carotid arterial duplex will be requested in patients prepared for coronary artery bypass graft (CABG).
Patient will be premedicated by intramuscular injection of 10mg morphine in the morning of the operation. Before induction of anesthesia, a five-lead electrocardiography system will be applied to monitor heart rate, rhythm, and ST segments (leads II and V5). A pulse oximeter probe will be attached, and a peripheral venous cannula will be placed. For measurement of arterial pressure and blood sampling, a 20 G cannula will be inserted into either right or left radial artery under local anesthesia. General anesthesia will be induced by fentanyl (3-5 μg/kg), propofol titrated according to response, followed by atracurium (0.5 mg/kg).
Trachea will be intubated, patients will be mechanically ventilated with oxygen in air so as to achieve normocarbia. This will be confirmed by radial arterial blood gas analysis. An esophageal temperature probe and a Foley catheter will also be placed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Patients 18 years of age or older
- •Elective cardiovascular surgery requiring cardiopulmonary bypass either for CABG or valve replacement.
排除标准
- •Patients with emergency surgeries.
- •Off pump heart surgery.
- •Hepatic affection (INR>2).
- •Renal affection (creatinine >1.6 mg/dl for men and >1.4 mg/dl for women).
- •Peripheral vascular disease affecting upper limbs.
- •Patients taking the antidiabetic sulphonylurea glyburide ( glibenclamide) or receiving nicorandil drug therapy will be excluded because these agents have been shown to abolish preconditioning.
- •Patients being considered for radial artery conduit harvesting.
结局指标
主要结局
Serum lactate level
时间窗: 1 minute at the end of operation
mmol/l from arterial blood gas sample
次要结局
- Serum creatinine level(72 hours postoperatively)
- Acute kidney injury (AKI) score(72 hours postoperatively)
- Serum sodium level(5 minutes before beginning of operation)
- Serum lactate level(72 hours postoperatively.)
- Heart rate(Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia)
- Left ventricular ejection fraction (LVEF)(48 hours after the operation)
- Central venous pressure(1 minute after the end of operation)
- Arterial oxygen pressure(Every 6 hours for 24 hours in the ICU)
- Arterial carbon dioxide pressure(Every 6 hours for 24 hours in the ICU)
- Power of hydrogen (pH)(Every 6 hours for 24 hours in the ICU)
- Standard bicarbonate level(Every 6 hours for 24 hours in the ICU)
- Diastolic blood pressure(Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia and no pulsatile blood pressure)
- Left ventricular fractional shortening (LVFS)(72 hours after the operation)
- Serum potassium level(5 minutes after ICU admission)
- Systolic blood pressure(Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia and no pulsatile blood pressure)
- Serum urea level(5 minutes after ICU admission)
研究者
Mohamed Ahmed Hamed
Lecturer of anesthesia
Fayoum University