Dexmedetomidine Effect on Mitochondrial Function
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.
研究概览
详细说明
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:
- After isolating lymphocytes, we will use high content imaging (HCI) to assess mitochondrial function and morphology. The lymphocytes will be stained with tetramethylrhodamine methyl ester (TMRM), which stains mitochondria in proportion to mitochondrial membrane potential, giving a metric for mitochondrial function. In addition, the cells will be stained with MitoTracker Green®, which can be used to assess mitochondrial morphology. Mitochondrial morphology will be quantified in a non-biased fashion using a mathematical image analysis algorithm.
- After extraction of genomic DNA, total cellular mitochondrial biomass and mitochondrial DNA damage will be measured using traditional and long-patch quantitative polymerase chain reaction (PCR).
Myocardial tissue will be also collected prior to closure of the atriotomy. Samples will be placed into 3% buffered glutaraldehyde at the time of biopsy, and imaging of mitochondrial structure using electron microscopy will be performed.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Ontario
-
Toronto、Ontario、加拿大、M5G1X8
- 招聘中
- Hospital for Sick Children
-
首席研究员:
- James D O'Leary, MBBCh
-
副研究员:
- John Coles, MD
-
副研究员:
- Jason T Maynes, MD PhD
-
副研究员:
- Daniel Stocki
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- aged between 3 - 36 months
- having primary corrective heart surgery
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较: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.
|
其他名称:
|
|
实验性的: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.
|
A bolus dose of 0.5 mcg/kg infused over 10 minutes will be administered, followed by a continuous infusion for the duration of the surgery at 0.6 mcg/kg/hr.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mitochondrial function (use high content imaging (HCI)
大体时间:Intraoperative
|
The primary outcomes for mitochondria will be grouped into mitochondrial function, morphology, content and mtDNA damage.
|
Intraoperative
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Creatinine level (Marker of acute renal injury)
大体时间:Postoperative day 1
|
Marker of acute renal injury
|
Postoperative day 1
|
|
Cardiac function (Left ventricular ejection fraction measured by trans-thoracic echocardiography)
大体时间:Postoperative day 1
|
Left ventricular ejection fraction measured by trans-thoracic echocardiography
|
Postoperative day 1
|
|
Inotropes and vasopressors (Duration and dose of inotropes and vasopressors after surgery)
大体时间:Postoperative day 1
|
Duration and dose of inotropes and vasopressors after surgery
|
Postoperative day 1
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Analgesic effects (Morphine equivalent dose of narcotics consumed)
大体时间:Perioperative (from induction of anesthesia for 24 hours)
|
Morphine equivalent dose of narcotics consumed
|
Perioperative (from induction of anesthesia for 24 hours)
|
|
Sedative effects (Duration of intubation)
大体时间:Perioperative (from induction of anesthesia for 24 hours)
|
Duration of intubation.
|
Perioperative (from induction of anesthesia for 24 hours)
|
合作者和调查者
调查人员
- 首席研究员:James D O'Leary, MBBCh、The Hospital for Sick Children
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.