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

June 22, 2011 updated by: Air Force Military Medical University, China

National Natural Science Foundation of China

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Xi'an, Shanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

2-12 years old children undergoing all types of open-heart surgery were included.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Electro-acupuncture, Control
Device: Electrical acupuncture stimulation
electroacupuncture would be administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery.
Other Names:
  • Suzhou Hua Tuo Medical Instruments Co, Ltd, Suzhou, China
Preconditioning, No preconditioning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Collaborators

National Natural Science Foundation of China

Investigators

  • Principal Investigator: Xin-Li Ni, PhD, Department of Anesthesiology of Xijing Hospital
  • Study Chair: Li-Ze Xiong, PhD, Xijing Hospital of Fouth Military Medical University
  • Study Director: Qiang Wang, PhD, Department of Anesthesiology of Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

October 22, 2010

First Submitted That Met QC Criteria

October 22, 2010

First Posted (Estimate)

October 25, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSFC3090091-6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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