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

NCT03297658 | Completed FDA Device

• 1 other identifier: 1610318932
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Congenital Heart Defect

Outcome Measures

Primary Outcomes (1)

• Change in Troponin level

  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 Outcomes (2)

• Evaluate the incidence and severity of pain in the post operative period

  every 2 hours for 48 hours after arrival in Pediatric Intensive Care Unit (PICU)

• Evaluate Acute Kidney Injury

  baseline and 6,12,24, and 48 hours after weaning from Cardiopulmonary bypass

Study Arms (2)

electro-acupuncture (EA) intervention

ACTIVE COMPARATOR

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)

sham electro acupuncture

SHAM COMPARATOR

Micro electrodes will be placed at PC 4 and 6 , LI 4 and ST36. subjects Receive sham (control) will not have stimulation.

Device: sham

Interventions

electro-acupuncture (EA) DEVICE

stimulation of acupuncture points related to congenital heart surgery for comfort heart and renal health

electro-acupuncture (EA) intervention

sham DEVICE

Micro electrodes will be placed but there will be no stimulation

sham electro acupuncture

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• Rosen DA, Unger K, Gustafson RA, Trieu C, Zeltzer LK, Lin YC. Electroacupuncture Addition to the Anesthesia Care of Pediatric Patients for Congenital Heart Surgery. J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1497-1504. doi: 10.1053/j.jvca.2017.02.037. Epub 2017 Feb 8. No abstract available.

  PMID: 28526209 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David A Rosen, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All subjects will have electro-acupuncture pads applied at four points bilaterally: pericardial 4 (PC 4), pericardial 6 (PC 6), large intestine 4 (LI 4) and stomach 36 (ST 36). No needles will be used. (Appendix A; 1) Group 1: Receive electro-acupuncture (EA) (treatment) frequency will be at 2Hz and 100 Hz the amplitude will be microA. Group 2: Receive sham (control) will not have stimulation.

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: September 29, 2017
• Study Start: November 15, 2017
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)