Randomized Controlled Trial of the Effects of Electroacupuncture Preconditioning in Children Undergoing Cardiac Surgery

• Conditions: Congenital Heart Defects
• Interventions: Device: Electrical acupuncture stimulation

• Registration Number: NCT01227096
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2010-10
• Study Start: 2010-10
• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-10-22
• Study First Posted: 2010-10-25
• Primary Completion: 2011-05
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Electro-acupuncture, Control	Electrical acupuncture stimulation	-

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shanxi, China