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Clinical Trials/NCT01227096
NCT01227096
Unknown
Not Applicable

National Natural Science Foundation of China

Air Force Military Medical University, China1 site in 1 country60 target enrollmentOctober 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Defects
Sponsor
Air Force Military Medical University, China
Enrollment
60
Locations
1
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
July 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Air Force Military Medical University, China

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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