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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 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03297658
Study type Interventional
Source West Virginia University
Contact David Rosen, MD
Phone 304-598-4263
Email rosend@wvumedicine.org
Status Recruiting
Phase N/A
Start date November 15, 2017
Completion date December 30, 2020
View Details
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