Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective
Arm
electrical acupuncture stimulation Suzhou Hua Tuo Medical Instruments Co, Ltd, Suzhou, China
electroacupuncture would be administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery.

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Fourth Military Medical University.