NCT01227096

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

June 23, 2011

Status Verified

October 1, 2010

Enrollment Period

7 months

First QC Date

October 22, 2010

Last Update Submit

June 22, 2011

Conditions

Congenital Heart Defects

Keywords

electroacupuncture pediatric cardioprotection

Study Arms (2)

Electro-acupuncture, Control

Device: Electrical acupuncture stimulation

Preconditioning, No preconditioning

Interventions

Electrical acupuncture stimulationDEVICE

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
Electro-acupuncture, Control

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi’an, Shanxi, 710032, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Xin-Li Ni, PhD

    Department of Anesthesiology of Xijing Hospital

    PRINCIPAL INVESTIGATOR

  • Li-Ze Xiong, PhD

    Xijing Hospital of Fouth Military Medical University

    STUDY CHAIR

  • Qiang Wang, PhD

    Department of Anesthesiology of Xijing Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2010

First Posted

October 25, 2010

Study Start

October 1, 2010

Primary Completion

May 1, 2011

Study Completion

July 1, 2011

Last Updated

June 23, 2011

Record last verified: 2010-10

Locations

CN(1)