Clinical trial NCT03297658: Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.
Official title: Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defect
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 59
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Troponin level
timeFrame: baseline and 6 hours after weaning from cardiopulmonary bypass
Secondary outcomes:
measure: Evaluate the incidence and severity of pain in the post operative period
timeFrame: every 2 hours for 48 hours after arrival in Pediatric Intensive Care Unit (PICU)
measure: Evaluate Acute Kidney Injury
timeFrame: baseline and 6,12,24, and 48 hours after weaning from Cardiopulmonary bypass
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: David A Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.