The Protective Effect of the α2-agonist Dexmedetomidine on Mitochondrial Structure and Function for Children With Non-cyanotic Congenital Heart Defects Having Cardiac Surgery: A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Mitochondrial function (use high content imaging (HCI)
研究概览
简要总结
The investigators hypothesize that in addition to a known sympatholytic effect, intraoperative dexmedetomidine reduces adverse changes in mitochondrial function and structure attenuating ischaemia-reperfusion and end-organ injury for children with non cyanotic congenital heart defects having corrective heart surgery.
详细描述
PICO: For children with non cyanotic congenital heart defects having corrective heart surgery (P) does intraoperative dexmedetomidine (I) reduce real-time changes in mitochondrial function and content (O) compared with children not receiving dexmedetomidine (C).
The study drug (dexmedetomidine or placebo) will be mixed in a standardized syringe of 4mcg/mL for active syringes or 50mL 0.9% sodium chloride for placebo. Blinded syringes will be prepared by the Research Support Pharmacy.
Administration is via the existing central venous line. A bolus dose of 0.125mL/kg (0.5 mcg/kg dexmedetomidine) infused over 10 minutes will be administered, followed by a continuous infusion for the duration of the surgery. The dexmedetomidine/placebo continuous infusion (CI) dose will run at 0.15mL/kg/hr (0.6 mcg/kg/hr dexmedetomidine).
Blood samples will be obtained from each child at three points in the operating room: 1) after the induction of anesthesia, 2) at the first separation from CPB (prior to administration of blood products), and 3) at the end of the surgery.
Samples obtained will be analyzed for mitochondrial function and morphology, total cellular mitochondrial biomass, and mitochondrial deoxyribonucleic acid (mtDNA) damage:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 3 - 36 months
- •having primary corrective heart surgery
排除标准
- •recent surgery (< 3 months)
- •previous chemotherapy
- •previous transfusion of blood products
- •neurodevelopmental disorders (including Trisomy 21)
- •supplemental oxygen requirement (< 3 months)
- •asthma requiring regular therapy
- •obstructive sleep apnea
- •the presence of concurrent infection or inflammation
- •a known allergy to dexmedetomidine hydrochloride
研究组 & 干预措施
Placebo (0.9% Saline)
0.9% Saline: bolus dose of 0.125mL/kg infused over 10 minutes, followed by a continuous infusion (CI) dose at 0.15mL/kg/hr for the duration of surgery.
干预措施: 0.9% NaCl (Drug)
Dexmedetomidine
Dexmedetomidine: bolus dose of 0.5 mcg/kg infused over 10 minutes, followed by a continuous infusion (CI) dose at 0.6 mcg/kg/hr for the duration of surgery.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Mitochondrial function (use high content imaging (HCI)
时间窗: Intraoperative
The primary outcomes for mitochondria will be grouped into mitochondrial function, morphology, content and mtDNA damage.
次要结局
- Inotropes and vasopressors (Duration and dose of inotropes and vasopressors after surgery)(Postoperative day 1)
- Creatinine level (Marker of acute renal injury)(Postoperative day 1)
- Cardiac function (Left ventricular ejection fraction measured by trans-thoracic echocardiography)(Postoperative day 1)
研究者
James O'Leary
Staff Anesthesiologist
The Hospital for Sick Children