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

Congenital Heart Defects Clinical Trial

Official title:

National Natural Science Foundation of China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01227096
• Other study ID #: NSFC3090091-6
• Status: Active, not recruiting
• Phase: N/A
• First received: October 22, 2010
• Last updated: June 22, 2011
• Start date: October 2010
• Est. completion date: July 2011

Study information

• Verified date: October 2010
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital

Intervention

Device:
• Electrical acupuncture stimulation
electroacupuncture would be administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Fourth Military Medical University	National Natural Science Foundation of China

Country where clinical trial is conducted

China,