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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Congenital Heart Defects

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Electro-acupuncture, Control

Electrical acupuncture stimulation

Intervention Type DEVICE

electroacupuncture would be administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery.

Preconditioning, No preconditioning

No interventions assigned to this group

Interventions

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Electrical acupuncture stimulation

electroacupuncture would be administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery.

Intervention Type DEVICE

Other Intervention Names

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Suzhou Hua Tuo Medical Instruments Co, Ltd, Suzhou, China

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No