Congenital Heart Defect Clinical Trial
Official title:
Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | West Virginia University | Morgantown | West Virginia |
Lead Sponsor | Collaborator |
---|---|
West Virginia University |
United States,
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
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 |
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