<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03297658</url>
  </required_header>
  <id_info>
    <org_study_id>EA in children with CHD</org_study_id>
    <nct_id>NCT03297658</nct_id>
  </id_info>
  <brief_title>Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.</brief_title>
  <official_title>Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single site, randomized, blinded, sham controlled, parallel group study to identify&#xD;
      whether electro-acupuncture (EA) is a beneficial anesthesia adjunct in children undergoing&#xD;
      procedures on their congenital heart defects (CHD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This investigation is a single site, randomized, blinded, sham controlled, parallel group&#xD;
      study to identify whether EA is a beneficial anesthesia adjunct in children undergoing&#xD;
      procedures on their congenital heart defects.&#xD;
&#xD;
      Study subjects age's birth to eighteen years, undergoing cardiac surgery for their congenital&#xD;
      heart lesions will be considered for entrance into the study. The randomized subjects will&#xD;
      receive either EA or sham during their surgery for CHD. Subjects are expected to remain in&#xD;
      the hospital 48 hours post procedure. Standard of care blood samples will be obtained&#xD;
      pre-operative and post-operative. The only study specific blood sample will be Troponin I&#xD;
      levels which will be obtained before surgery begins after the IV lines have been placed, and&#xD;
      6 hours after bypass. Urine samples will be obtained before surgery after placement of the&#xD;
      foley catheter and every 6 hours post bypass aortic cross clamp removal for 48 hours while&#xD;
      the foley catheter is still in place.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 15, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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)&#xD;
Group 1: Receive electro-acupuncture (EA) (treatment) frequency will be at 2Hz and 100 Hz the amplitude will be microA.&#xD;
Group 2: Receive sham (control) will not have stimulation.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Troponin level</measure>
    <time_frame>baseline and 6 hours after weaning from cardiopulmonary bypass</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the incidence and severity of pain in the post operative period</measure>
    <time_frame>every 2 hours for 48 hours after arrival in Pediatric Intensive Care Unit (PICU)</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate Acute Kidney Injury</measure>
    <time_frame>baseline and 6,12,24, and 48 hours after weaning from Cardiopulmonary bypass</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Congenital Heart Defect</condition>
  <arm_group>
    <arm_group_label>electro-acupuncture (EA) intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham electro acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Micro electrodes will be placed at PC 4 and 6 , LI 4 and ST36. subjects Receive sham (control) will not have stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>electro-acupuncture (EA)</intervention_name>
    <description>stimulation of acupuncture points related to congenital heart surgery for comfort heart and renal health</description>
    <arm_group_label>electro-acupuncture (EA) intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham</intervention_name>
    <description>Micro electrodes will be placed but there will be no stimulation</description>
    <arm_group_label>sham electro acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 0-18 years of age undergoing procedures on their congenital heart defects&#xD;
             where an aortic cross clamp will be placed.&#xD;
&#xD;
        Additionally, patients with coarctation of the aorta for repair will be considered as a&#xD;
        separate group and eligible for enrollment.&#xD;
&#xD;
          -  Willing to provide written Assent/Consent in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with skin lesions over more than 50% of EA sites.&#xD;
&#xD;
          -  Patients in renal failure.&#xD;
&#xD;
          -  Patients on chronic opioid therapy.&#xD;
&#xD;
          -  Unwilling to provide written Assent/Consent in English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David A Rosen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Rosen, MD</last_name>
    <phone>304-598-4263</phone>
    <email>rosend@wvumedicine.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Rosen, MD</last_name>
      <phone>304-598-4263</phone>
      <email>rosend@wvumedicine.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>28526209</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>February 14, 2020</last_update_submitted>
  <last_update_submitted_qc>February 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West Virginia University</investigator_affiliation>
    <investigator_full_name>David Rosen, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Defects, Congenital</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03297658/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03297658
org study id: EA in children with CHD
nct id: NCT03297658
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
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: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in Troponin level
time frame: baseline and 6 hours after weaning from cardiopulmonary bypass
description: 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.
measure: Evaluate the incidence and severity of pain in the post operative period
time frame: every 2 hours for 48 hours after arrival in Pediatric Intensive Care Unit (PICU)
description: 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).
measure: Evaluate Acute Kidney Injury
time frame: baseline and 6,12,24, and 48 hours after weaning from Cardiopulmonary bypass
description: 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.
arm group label: electro-acupuncture (EA) intervention
arm group type: Active Comparator
description: 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.
arm group label: sham electro acupuncture
arm group type: Sham Comparator
description: Micro electrodes will be placed at PC 4 and 6 , LI 4 and ST36. subjects Receive sham (control) will not have stimulation.
intervention type: Device
intervention name: electro-acupuncture (EA)
description: stimulation of acupuncture points related to congenital heart surgery for comfort heart and renal health
arm group label: electro-acupuncture (EA) intervention
intervention type: Device
intervention name: sham
description: Micro electrodes will be placed but there will be no stimulation
arm group label: sham electro acupuncture
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: David A Rosen, MD
role: Principal Investigator
affiliation: West Virginia University
last name: David Rosen, MD
phone: 304-598-4263
email: rosend@wvumedicine.org
facility: 
status: Recruiting
contact: 
country: United States
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.
PMID: 28526209
responsible party type: Principal Investigator
investigator affiliation: West Virginia University
investigator full name: David Rosen, MD
investigator title: Principal Investigator
mesh term: Heart Defects, Congenital
sharing ipd: No
provided document: 