Effect of Cyclosporine and Remote Ischemic Preconditioning in Reperfusion Ischemia Injury on Tetralogy Fallot Patients With Correction Surgery
- Conditions
- Myocardial InjuryCardiac Surgery
- Interventions
- Registration Number
- NCT05691764
- Lead Sponsor
- Indonesia University
- Brief Summary
The study aimed to evaluate the combined effects of cyclosporine and remote ischemic preconditioning on MDA, calcium cytosol concentration, and mitochondrial edema in tetralogy Fallot patients undergoing corrective surgery.
- Detailed Description
Forty patients undergoing tetralogy Fallot corrective surgery were randomized to RIPC and cyclosporine (n=20) and control (n=20). Cyclosporin was administered 2 hour pre induction of anesthesia with the dose of 3 mg/kg body weight intravenously. RIPC was performed preoperatively after induction of anesthesia by inflating pressure cuff on the extremity 30 mmHg higher than systolic blood pressure of the patient for 5x5 minutes with 5 minutes reperfusion interval. Blood samples from coronary sinus and biopsies from the myocardial infundibulum were obtained three times at the condition of pre ischemic, ischemic, and reperfusion. MDA was measured from the blood samples, meanwhile calcium cytosol concentration and mitochondrial edema was measured from the biopsy samples.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Tetralogy Fallot patient that is undergoing correction surgery
- Has an ideal anatomy for corrective surgery, namely: Pulmonary artery size within normal limits (according to the kirklin table), Mc Goon ratio> 1.5, Nakata index> 200, normal coronary artery ostium and good biventricular function.
- Patient refuses the procedure
- Patient with acute kidney injury
- Patient without lower extremity
- Patient with cyclosporin allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cyclosporin + RIPC remote ischemic preconditioning This group received cyclosporin intravenously 2 hours pre-induction of anesthesia, with the dose of 3 mg/ kg body weight. RIPC was performed preoperatively after induction of anesthesia by inflating pressure cuff on the extremity 30 mmHg higher than systolic blood pressure of the patient for 5x5 minutes with 5 minutes reperfusion interval. Control Placebo This group received placebo intravenously 2 hours pre-induction of anesthesia. Cyclosporin + RIPC Cyclosporin This group received cyclosporin intravenously 2 hours pre-induction of anesthesia, with the dose of 3 mg/ kg body weight. RIPC was performed preoperatively after induction of anesthesia by inflating pressure cuff on the extremity 30 mmHg higher than systolic blood pressure of the patient for 5x5 minutes with 5 minutes reperfusion interval.
- Primary Outcome Measures
Name Time Method Malondialdehyde (MDA) 1 year ROS level is determined by measuring MDA concentration (nmol/mL)
Mitochondrial edema 1 year Mitochondrial edema (%) is measured by decreasing of optical density that indicates change in mitochondrial matrix volume.
Calcium cytosol concentration 1 year Calcium concentration (nmol/mL) in cytosol is determined by ratiometric analysis on Fura Red- dyed heart cells.
- Secondary Outcome Measures
Name Time Method Creatine kinase- MB (CKMB) 1 year Measured from venous blood, unit of measurement is units per liter (IU/L).
Troponin I 1 year Measured from venous blood, unit of measurement is nanograms per milliliter (ng/mL).
Vasoactive inotropic score (VIS) 1 year VIS was calculated as: dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min).
Cardiac index 1 year Examined with echocardiography, unit of measurement is litres per minute per square metre (L/min/m2).
Trial Locations
- Locations (1)
Indonesia University
🇮🇩Jakarta, DKI Jakarta, Indonesia