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

October 22, 2010
June 22, 2011
October 2010
May 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01227096 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Randomized Controlled Trial of the Effects of Electroacupuncture Preconditioning in Children Undergoing Cardiac Surgery
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:

blood serum

Probability Sample

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

Congenital Heart Defects
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
  • Electro-acupuncture, Control
    Intervention: Device: Electrical acupuncture stimulation
  • Preconditioning, No preconditioning
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
July 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
2 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01227096
NSFC3090091-6
Yes
Xiong Li-Ze, Xijing Hospital of Fourth Military Medical University
Fourth Military Medical University
National Natural Science Foundation of China
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
Fourth Military Medical University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP