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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01227096
Other study ID # NSFC3090091-6
Secondary ID
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


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, 

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