Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Change in Troponin level
研究概览
简要总结
This is a single site, randomized, blinded, sham controlled, parallel group study to identify whether electro-acupuncture (EA) is a beneficial anesthesia adjunct in children undergoing procedures on their congenital heart defects (CHD).
详细描述
This investigation is a single site, randomized, blinded, sham controlled, parallel group study to identify whether EA is a beneficial anesthesia adjunct in children undergoing procedures on their congenital heart defects.
Study subjects age's birth to eighteen years, undergoing cardiac surgery for their congenital heart lesions will be considered for entrance into the study. The randomized subjects will receive either EA or sham during their surgery for CHD. Subjects are expected to remain in the hospital 48 hours post procedure. Standard of care blood samples will be obtained pre-operative and post-operative. The only study specific blood sample will be Troponin I levels which will be obtained before surgery begins after the IV lines have been placed, and 6 hours after bypass. Urine samples will be obtained before surgery after placement of the foley catheter and every 6 hours post bypass aortic cross clamp removal for 48 hours while the foley catheter is still in place.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 0-18 years of age undergoing procedures on their congenital heart defects where an aortic cross clamp will be placed.
- •Additionally, patients with coarctation of the aorta for repair will be considered as a separate group and eligible for enrollment.
- •Willing to provide written Assent/Consent in English.
排除标准
- •Patients with skin lesions over more than 50% of EA sites.
- •Patients in renal failure.
- •Patients on chronic opioid therapy.
- •Unwilling to provide written Assent/Consent in English.
结局指标
主要结局
Change in Troponin level
时间窗: baseline and 6 hours after weaning from cardiopulmonary bypass
Troponin level Change from baseline. Troponin lab levels will be measured as a marker of myocardial injury. Children undergoing procedures for their congenital heart disease will have their troponin levels prior to the procedure and 6 hours after weaning from bypass. This study will look at differences between pre and post troponin values in the two groups.
次要结局
- Evaluate the incidence and severity of pain in the post operative period(every 2 hours for 48 hours after arrival in Pediatric Intensive Care Unit (PICU))
- Evaluate Acute Kidney Injury(baseline and 6,12,24, and 48 hours after weaning from Cardiopulmonary bypass)
研究者
David Rosen, MD
Principal Investigator
West Virginia University