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
- 1
- 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.
研究组 & 干预措施
Control group
control group will have non inflated cuff around the arm.
干预措施: Non inflated cuff (Device)
RIPC group
Inflated cuff will be done systematically and regularly
干预措施: Inflated cuff (Device)
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 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)
- Serum urea level(5 minutes after ICU admission)
- Serum creatinine level(72 hours postoperatively)
- Acute kidney injury (AKI) score(72 hours postoperatively)
- Serum sodium level(5 minutes before beginning of operation)
- 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 lactate level(3 minutes after induction of anesthesia)
- Serum lactate level(30 minutes, after cardiopulmonary bypass)
- Serum lactate level(1 minute before cardiopulmonary bypass)
- Serum lactate level(24 hours postoperatively.)
- Serum lactate level(48 hours postoperatively.)
- Heart rate(2 minutes before induction of general anesthesia)
- Heart rate(3 minutes after induction of general anesthesia)
- Systolic blood pressure(2 minutes before induction of general anesthesia)
- Systolic blood pressure(3 minutes after induction)
- Diastolic blood pressure(2 minutes before induction of general anesthesia)
- Diastolic blood pressure(3 minutes after induction)
- Left ventricular fractional shortening (LVFS)(12 hours before the operation)
- Left ventricular fractional shortening (LVFS)(2 hours after the operation)
- Left ventricular fractional shortening (LVFS)(4 hours after the operation)
- Left ventricular fractional shortening (LVFS)(12 hours after the operation)
- Left ventricular fractional shortening (LVFS)(24 hours after the operation)
- Left ventricular fractional shortening (LVFS)(48 hours after the operation)
- Left ventricular ejection fraction (LVEF)(12 hours before the operation)
- Left ventricular ejection fraction (LVEF)(2 hours after the operation)
- Left ventricular ejection fraction (LVEF)(4 hours after the operation)
- Left ventricular ejection fraction (LVEF)(12 hours after the operation)
- Left ventricular ejection fraction (LVEF)(24 hours after the operation)
- Central venous pressure(Baseline 2 minutes after insertion of central venous catheter)
- Central venous pressure(2 minutes before cardiopulmonary bypass)
- Central venous pressure(2 minutes after cardiopulmonary bypass)
- Serum urea level(5 minutes before beginning of operation)
- Serum creatinine level(5 minutes before beginning of operation)
- Serum creatinine level(24 hours postoperatively)
- Serum creatinine level(48 hours postoperatively)
- Acute kidney injury (AKI) score(24 hours postoperatively)
- Acute kidney injury (AKI) score(48 hours postoperatively)
- Serum sodium level(5 minutes after ICU admission.)
- Serum potassium level(5 minutes before beginning of operation)
- Arterial oxygen pressure(5 minutes before operation)
- Arterial oxygen pressure(2 minutes before cardiopulmonary bypass)
- Arterial oxygen pressure(2 minutes after cardiopulmonary bypass)
- Arterial oxygen pressure(1 minute after end of operation)
- Arterial carbon dioxide pressure(5 minutes before operation)
- Arterial carbon dioxide pressure(2 minutes before cardiopulmonary bypass)
- Arterial carbon dioxide pressure(2 minutes after cardiopulmonary bypass)
- Arterial carbon dioxide pressure(1 minute after end of operation)
- Power of hydrogen (pH)(5 minutes before operation)
- Power of hydrogen (pH)(2 minutes before cardiopulmonary bypass)
- Power of hydrogen (pH)(2 minutes after cardiopulmonary bypass)
- Power of hydrogen (pH)(1 minute after end of operation)
- Standard bicarbonate level(5 minutes before operation)
- Standard bicarbonate level(2 minutes before cardiopulmonary bypass)
- Standard bicarbonate level(2 minutes after cardiopulmonary bypass)
- Standard bicarbonate level(1 minute after end of operation)
研究者
Mohamed Ahmed Hamed
Lecturer of anesthesia
Fayoum University