Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.

August 19, 2024 updated by: David Rosen, MD, West Virginia University
This is a single site, randomized, blinded, sham controlled, parallel group study to identify whether electro-acupuncture (EA) is a beneficial anesthesia adjunct in children undergoing procedures on their congenital heart defects (CHD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This investigation is a single site, randomized, blinded, sham controlled, parallel group study to identify whether EA is a beneficial anesthesia adjunct in children undergoing procedures on their congenital heart defects.

Study subjects age's birth to eighteen years, undergoing cardiac surgery for their congenital heart lesions will be considered for entrance into the study. The randomized subjects will receive either EA or sham during their surgery for CHD. Subjects are expected to remain in the hospital 48 hours post procedure. Standard of care blood samples will be obtained pre-operative and post-operative. The only study specific blood sample will be Troponin I levels which will be obtained before surgery begins after the IV lines have been placed, and 6 hours after bypass. Urine samples will be obtained before surgery after placement of the foley catheter and every 6 hours post bypass aortic cross clamp removal for 48 hours while the foley catheter is still in place.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

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

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients 0-18 years of age undergoing procedures on their congenital heart defects where an aortic cross clamp will be placed.

Additionally, patients with coarctation of the aorta for repair will be considered as a separate group and eligible for enrollment.

  • Willing to provide written Assent/Consent in English.

Exclusion Criteria:

  • Patients with skin lesions over more than 50% of EA sites.
  • Patients in renal failure.
  • Patients on chronic opioid therapy.
  • Unwilling to provide written Assent/Consent in English.

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: electro-acupuncture (EA) intervention
Micro electrodes will be placed at PC 4 and 6 , LI 4 and ST36. subjects will receive electro-acupuncture (EA) (treatment) mixed frequency( continuous plus dense disperse) will be at 2Hz and 100 Hz the amplitude will be 1000 microA.
Device: electro-acupuncture (EA)
stimulation of acupuncture points related to congenital heart surgery for comfort heart and renal health
Sham Comparator: sham electro acupuncture
Micro electrodes will be placed at PC 4 and 6 , LI 4 and ST36. subjects Receive sham (control) will not have stimulation.
Device: sham
Micro electrodes will be placed but there will be no stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Troponin level
Time Frame: baseline and 6 hours after weaning from cardiopulmonary bypass
Troponin level Change from baseline. Troponin lab levels will be measured as a marker of myocardial injury. Children undergoing procedures for their congenital heart disease will have their troponin levels prior to the procedure and 6 hours after weaning from bypass. This study will look at differences between pre and post troponin values in the two groups.
baseline and 6 hours after weaning from cardiopulmonary bypass

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the incidence and severity of pain in the post operative period
Time Frame: every 2 hours for 48 hours after arrival in Pediatric Intensive Care Unit (PICU)
Subjects less than 2 month will have their pain assessed every 2 hours for 48 hours using the Neonatal Infant Pain Scale (NIPS).Pain in children 2 months to 7 years or those that are unable to communicate their pain will have their pain evaluated every 2 hours for 48 hours using the Face, Legs, Cry, Consolability Scale (FLACC). Scale range 0-10. Children older than 10 will have their pain evaluated every 2 hours for 48 hours using a Visual analogue scale (0-10).
every 2 hours for 48 hours after arrival in Pediatric Intensive Care Unit (PICU)
Evaluate Acute Kidney Injury
Time Frame: baseline and 6,12,24, and 48 hours after weaning from Cardiopulmonary bypass
Acute Kidney Injury (AKI) classification will be assessed using the AKIN classification system. This system uses Serum Creatinine and/or Urine output to come up with a staging of 1-3. Patients will be stage at 6, 12, 24, and 48 hours after bypass.
baseline and 6,12,24, and 48 hours after weaning from Cardiopulmonary bypass

Collaborators and Investigators

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

Sponsor

West Virginia University

Investigators

  • Principal Investigator: David A Rosen, MD, West Virginia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 15, 2017

Primary Completion (Actual)

August 14, 2024

Study Completion (Actual)

August 14, 2024

Study Registration Dates

First Submitted

August 7, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 29, 2017

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1610318932

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

Clinical Trials on Congenital Heart Defect

Clinical Trials on electro-acupuncture (EA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe