Randomized Controlled Trial of the Effects of Electroacupuncture Preconditioning in Children Undergoing Cardiac Surgery
This trial is active, not recruiting.
|Condition||congenital heart defects|
|Treatment||electrical acupuncture stimulation|
|Sponsor||Fourth Military Medical University|
|Collaborator||National Natural Science Foundation of China|
|Start date||October 2010|
|End date||May 2011|
|Trial size||60 participants|
|Trial identifier||NCT01227096, NSFC3090091-6|
The purpose of this study is to determine whether electroacupuncture preconditioning would provide protection against myocardial Ischemic-Reperfusion injury and systemic inflammation in children undergoing CPB for repair of congenital heart defects.
|Observational model||case control|
Male or female participants from 2 years up to 12 years old.
Inclusion Criteria: - Aged 2-12 years children undergoing repair of congenital heart defects without server pulmonary arterial hypertension or systematic disease. - Get an informed consent from parental. Exclusion Criteria: - Patient's age is less than 2 years or more than 12 years. - Patient with isolated atrial septal defect undergoing repair via thoracoscope completion. - Patients with chromosomal defects, airway and parenchymal lung disease, immunodeficiency, or blood disorders. - Patients without an informed consent from parental.
|Official title||National Natural Science Foundation of China|
|Principal investigator||Xin-Li Ni, PhD|
|Description||2-12 years old children undergoing repair of congenital heart defects were included, except for those with server pulmonary arterial hypertension, chromosomal defects, airway and parenchymal lung disease, immunodeficiency, or blood disorders were excluded. Children were equal randomized to EAPC(electroacupuncture preconditioning)or control group. Electroacupuncture was administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery in EAPC group. Control patients underwent sham placement of the electrode the arm without stimulation. The duration of cardiopulmonary bypass and aortic cross-clamp time was recorded. Myocardial injury was assessed by cardiac heart-type fatty acid-binding protein (HFAP) and cardiac troponin I (cTnI>0.40 ng/mL). 8-isoprostane , C-reactive protein, cytokines were measured pre- and postoperatively.|
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