Effect of Cyclosporine and Remote Ischemic Preconditioning on MDA, Calcium Cytosol Concentration, and Mitochondrial Edema in Reperfusion Ischemia Injury: Research on Tetralogy Fallot Patients With Correction Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Malondialdehyde (MDA)
研究概览
简要总结
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.
详细描述
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.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient refuses the procedure
- •Patient with acute kidney injury
- •Patient without lower extremity
- •Patient with cyclosporin allergy
研究组 & 干预措施
Cyclosporin + RIPC
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.
干预措施: Cyclosporin (Drug)
Cyclosporin + RIPC
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.
干预措施: remote ischemic preconditioning (Procedure)
Control
This group received placebo intravenously 2 hours pre-induction of anesthesia.
干预措施: Placebo (Drug)
结局指标
主要结局
Malondialdehyde (MDA)
时间窗: 1 year
ROS level is determined by measuring MDA concentration (nmol/mL)
Mitochondrial edema
时间窗: 1 year
Mitochondrial edema (%) is measured by decreasing of optical density that indicates change in mitochondrial matrix volume.
Calcium cytosol concentration
时间窗: 1 year
Calcium concentration (nmol/mL) in cytosol is determined by ratiometric analysis on Fura Red- dyed heart cells.
次要结局
- Troponin I(1 year)
- Vasoactive inotropic score (VIS)(1 year)
- Cardiac index(1 year)
- Creatine kinase- MB (CKMB)(1 year)
研究者
Jefferson K Hidayat
Principal Investigator
Indonesia University