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

Congenital Heart Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03297658
• Other study ID #: EA in children with CHD
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2020
• Source: West Virginia University
• Contact: David Rosen, MD
• Phone: 304-598-4263
• Email: rosend[@]wvumedicine.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Defect
• Heart Defects, Congenital

Intervention

Device:
• electro-acupuncture (EA)
stimulation of acupuncture points related to congenital heart surgery for comfort heart and renal health
• sham
Micro electrodes will be placed but there will be no stimulation

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the incidence and severity of pain in the post operative period	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)
Secondary	Evaluate Acute Kidney Injury	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