Remote Ischemic Preconditioning During Cardiopulmonary Bypass
- Conditions
- Lactic Acidosis
- Interventions
- Device: Non inflated cuffDevice: Inflated cuff
- Registration Number
- NCT03723993
- Lead Sponsor
- Fayoum University
- Brief Summary
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.
- Detailed Description
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.
For drug infusion, a triple-lumen central venous catheter will be inserted via the right internal jugular vein.
Anesthesia will be maintained by inhaled isoflurane, with additional fentanyl injected prior to skin incision as well as sternotomy and atracurium infusion for continued muscle relaxation.
During extracorporeal circulation, patients will receive propofol infusion in addition to atracurium infusion.
Before initiation of cardiopulmonary bypass (CPB), the patients will receive intravenously tranexamic acid (2 g) and heparin (300-500 units/kg body weight) to achieve an activated clotting time \> 400 s. CPB was instituted via an ascending aortic cannula and a two-stage right atrial cannula. Before, during, and after CPB (pump blood flow: 2.4 l/min/m2), mean arterial pressure was adjusted to exceed 60 mmHg. Cardiac arrest will be induced with cold antegrade crystalloid cardioplegia (St Thomas solution) or warm intermittent antegrade blood cardioplegia. Lactate-enriched Ringer's solution will be added to the CPB circuit to maintain reservoir volume when needed, and packed red blood cells will be added when hemoglobin concentration decrease to less than 7 g/dl.
After rewarming the patient to 37°C and separation from CPB, reversal of heparin by protamine sulfate, and sternal closure, the patients will be transferred to the intensive care unit.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Patients 18 years of age or older
- Elective cardiovascular surgery requiring cardiopulmonary bypass either for CABG or valve replacement.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Non inflated cuff control group will have non inflated cuff around the arm. RIPC group Inflated cuff Inflated cuff will be done systematically and regularly
- Primary Outcome Measures
Name Time Method Serum lactate level 1 minute at the end of operation mmol/l from arterial blood gas sample
- Secondary Outcome Measures
Name Time Method Serum creatinine level 72 hours postoperatively mmol/L
Acute kidney injury (AKI) score 72 hours postoperatively Grade 1: serum creatinine rise of 150%-200% of baseline and/or urine output \<0.5 mL/kg/h for \>6 contiguous hours.
Grade 2: serum creatinine rise of 200%-300% of baseline and/or urine output \<0.5 mL/kg/h for \>12 contiguous hours.
Grade 3: serum creatinine rise of \>300% of baseline and/or urine output \<0.3 mL/kg/h for \>24 h or anuria for 12 h.Serum sodium level 5 minutes before beginning of operation milliequivalent/L
Serum lactate level 72 hours postoperatively. mmol/l from arterial blood gas sample
Heart rate Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia beat per minute from electrocardiogram
Left ventricular ejection fraction (LVEF) 48 hours after the operation measured in percentage derived from echocardiography
Central venous pressure 1 minute after the end of operation from central venous catheter measured in cm H2O
Arterial oxygen pressure Every 6 hours for 24 hours in the ICU From arterial blood gas sampling
Arterial carbon dioxide pressure Every 6 hours for 24 hours in the ICU From arterial blood gas sampling
Power of hydrogen (pH) Every 6 hours for 24 hours in the ICU From arterial blood gas sampling
Standard bicarbonate level Every 6 hours for 24 hours in the ICU From arterial blood gas sampling
Diastolic blood pressure Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia and no pulsatile blood pressure Measured by mmHg from invasive arterial blood pressure
Left ventricular fractional shortening (LVFS) 72 hours after the operation measured in percentage derived from echocardiography
Serum potassium level 5 minutes after ICU admission milliequivalent/L
Systolic blood pressure Every 30 minutes for 6 hours during surgery except at cardiopulmonary bypass as there is cardioplegia and no pulsatile blood pressure Measured by mmHg from invasive arterial blood pressure
Serum urea level 5 minutes after ICU admission mmol/L
Trial Locations
- Locations (1)
Mohamed Hamed
🇪🇬Fayoum, Egypt