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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Fourth Military Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by:
Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT01227096
First received: October 22, 2010
Last updated: June 22, 2011
Last verified: October 2010
  Purpose

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.


Condition Intervention
Congenital Heart Defects
Device: Electrical acupuncture stimulation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: National Natural Science Foundation of China

Resource links provided by NLM:


Further study details as provided by Fourth Military Medical University:

Biospecimen Retention:   Samples Without DNA

blood serum


Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Electro-acupuncture, Control Device: Electrical acupuncture stimulation
electroacupuncture would be administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery.
Other Name: Suzhou Hua Tuo Medical Instruments Co, Ltd, Suzhou, China
Preconditioning, No preconditioning

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.

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227096

Locations
China, Shanxi
Xijing Hospital
Xi'an, Shanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
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
  More Information

No publications provided

Responsible Party: Xiong Li-Ze, Xijing Hospital of Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01227096     History of Changes
Other Study ID Numbers: NSFC3090091-6
Study First Received: October 22, 2010
Last Updated: June 22, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Fourth Military Medical University:
electroacupuncture pediatric cardioprotection

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases

ClinicalTrials.gov processed this record on October 20, 2014