CClinicalTrials.gg
Status unknownNCT01227096Updated Jun 23, 2011

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

An observational study in Congenital Heart Defects, sponsored by Air Force Military Medical University, China. Status unknown at 1 site in China. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2011-06-23.

Sponsored by Air Force Military Medical University, China · Observational

The sponsor has not verified this record recently (last verified Oct 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
60
Ages
2 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Congenital Heart Defects

Keywords

  • electroacupuncture pediatric cardioprotection
03

In context

Heart Defects, Congenital

1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.

This study's planned enrollment of 60 is below the median of 121 across 442 observational studies indexed under Heart Defects, Congenital.

Browse Heart Defects, Congenital studies →

Lead sponsor

Air Force Military Medical University, China is the lead sponsor of 172 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
60 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Electro-acupuncture, Control

    Device: Electrical acupuncture stimulation

  • Preconditioning, No preconditioning

Interventions

  • DeviceElectrical acupuncture stimulation

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

    Also known as: Suzhou Hua Tuo Medical Instruments Co, Ltd, Suzhou, China

06

Study locations

1 site
  • Xijing Hospital
    Xi'an, Shanxi 710032, China
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01227096
Lead sponsor
Air Force Military Medical University, China
Collaborators
National Natural Science Foundation of China
First posted
Oct 25, 2010
Start date
Oct 2010
Primary completion
May 2011
Completion
Jul 2011 (estimated)
Last update
Jun 23, 2011

Study contacts

Xin-Li Ni, PhD
principal investigator · Department of Anesthesiology of Xijing Hospital
Li-Ze Xiong, PhD
study chair · Xijing Hospital of Fouth Military Medical University
Qiang Wang, PhD
study director · Department of Anesthesiology of Xijing Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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