<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/NCT02975999</url>
  </required_header>
  <id_info>
    <org_study_id>HRP-530</org_study_id>
    <nct_id>NCT02975999</nct_id>
  </id_info>
  <brief_title>Use of Vasopressin Following the Fontan Operation</brief_title>
  <official_title>Use of Vasopressin Following the Fontan Operation: Both Pilot and Multicenter Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advocate Health Care</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Advocate Health Care</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Vasopressin following the Fontan operation&#xD;
      will decrease chest tube output and duration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A pilot and subsequently a multicenter, randomized, double blinded clinical trial to evaluate&#xD;
      the use of vasopressin following the Fontan operation.&#xD;
&#xD;
      Phase one of the study will be a single center pilot study and will be conducted at Advocate&#xD;
      Children's Hospital, Oak Lawn IL. This will be a randomized and double blinded. Ten patients&#xD;
      will be enrolled with five patients as control group and five receiving Vasopressin.&#xD;
      Vasopressin levels will be obtained just prior to initiation of Vasopressin and 48 hours&#xD;
      later in the pilot study. Safety and effect size will be evaluated after this pilot study.&#xD;
&#xD;
      The multicenter study will be phase two and will be conducted in the cardiac operating rooms&#xD;
      and cardiac intensive care unit (CVICU) of 7 pediatric cardiovascular programs in the United&#xD;
      States. The investigators will be enrolling 12 subjects undergoing the Fontan operation from&#xD;
      each participating institution. Six patients will be randomly assigned to receive Vasopressin&#xD;
      while six will receive placebo.&#xD;
&#xD;
      A total of 84 patients undergoing the Fontan operation will be included in the study and&#xD;
      randomized to one of the two treatment groups.&#xD;
&#xD;
      Group 1 will include 42 subjects who will receive the treatment drug (Vasopressin) for 48&#xD;
      hours following the Fontan operation. Group 2 will include 42 subjects who will receive&#xD;
      placebo (normal saline) and will serve as a control group.&#xD;
&#xD;
      Drug administration protocol:&#xD;
&#xD;
      Vasopressin at a dose of 0.4 mU/kg/min will be started on subjects in the study group while&#xD;
      coming off cardiopulmonary bypass. The dose of Vasopressin will not be titrated. Study drug&#xD;
      drip will infuse for 48 hours after which will be discontinued.&#xD;
&#xD;
      The placebo group will be receiving normal saline at the same rate of the vasopressin group.&#xD;
      The treating physician will be blinded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Pilot study is finished, multi centered is not moving forward&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chest tube drainage</measure>
    <time_frame>From post operative day 0 through study completion, an average of 1 month</time_frame>
    <description>chest tube drainage in ml/kg/day until the day the chest tube is removed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>From the day of the surgery (post operative day 0) through study completion, an average of 1 month</time_frame>
    <description>Duration the patient remains in the hospital in days until the day of discharge home</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pleural Effusion</condition>
  <condition>Single-ventricle</condition>
  <arm_group>
    <arm_group_label>Vasopressin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vasopressin at 0.4mU/kg/min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vasopressin</intervention_name>
    <description>Vasopressin at dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.</description>
    <arm_group_label>Vasopressin</arm_group_label>
    <other_name>Vasostrict, arginine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Normal saline at starting dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.</description>
    <arm_group_label>Normal saline</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects between 1.5-7 years old undergoing Fontan operation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a planned fenestrated Fontan.&#xD;
&#xD;
          -  Patients undergoing revision surgery for failing Fontan.&#xD;
&#xD;
          -  Evidence of renal insufficiency prior to surgery defined by creatinine &gt;1 mg/dl.&#xD;
&#xD;
          -  Planned arch reconstruction at the time of the Fontan procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Advocate Children's Hospital</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>December 10, 2022</last_update_submitted>
  <last_update_submitted_qc>December 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ann &amp; Robert H Lurie Children's Hospital of Chicago</investigator_affiliation>
    <investigator_full_name>Jamie Penk</investigator_full_name>
    <investigator_title>Pediatric Cardiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion</mesh_term>
    <mesh_term>Univentricular Heart</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vasopressins</mesh_term>
    <mesh_term>Arginine Vasopressin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 9, 2023</submitted>
    <returned>August 31, 2023</returned>
  </pending_results>
  <!-- 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/NCT02975999
org study id: HRP-530
nct id: NCT02975999
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether Vasopressin following the Fontan operation
      will decrease chest tube output and duration.
A pilot and subsequently a multicenter, randomized, double blinded clinical trial to evaluate
      the use of vasopressin following the Fontan operation.

      Phase one of the study will be a single center pilot study and will be conducted at Advocate
      Children's Hospital, Oak Lawn IL. This will be a randomized and double blinded. Ten patients
      will be enrolled with five patients as control group and five receiving Vasopressin.
      Vasopressin levels will be obtained just prior to initiation of Vasopressin and 48 hours
      later in the pilot study. Safety and effect size will be evaluated after this pilot study.

      The multicenter study will be phase two and will be conducted in the cardiac operating rooms
      and cardiac intensive care unit (CVICU) of 7 pediatric cardiovascular programs in the United
      States. The investigators will be enrolling 12 subjects undergoing the Fontan operation from
      each participating institution. Six patients will be randomly assigned to receive Vasopressin
      while six will receive placebo.

      A total of 84 patients undergoing the Fontan operation will be included in the study and
      randomized to one of the two treatment groups.

      Group 1 will include 42 subjects who will receive the treatment drug (Vasopressin) for 48
      hours following the Fontan operation. Group 2 will include 42 subjects who will receive
      placebo (normal saline) and will serve as a control group.

      Drug administration protocol:

      Vasopressin at a dose of 0.4 mU/kg/min will be started on subjects in the study group while
      coming off cardiopulmonary bypass. The dose of Vasopressin will not be titrated. Study drug
      drip will infuse for 48 hours after which will be discontinued.

      The placebo group will be receiving normal saline at the same rate of the vasopressin group.
      The treating physician will be blinded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Chest tube drainage
time frame: From post operative day 0 through study completion, an average of 1 month
description: chest tube drainage in ml/kg/day until the day the chest tube is removed
measure: Length of hospital stay
time frame: From the day of the surgery (post operative day 0) through study completion, an average of 1 month
description: Duration the patient remains in the hospital in days until the day of discharge home
arm group label: Vasopressin
arm group type: Experimental
description: Vasopressin at 0.4mU/kg/min
arm group label: Normal saline
arm group type: Placebo Comparator
description: Normal saline will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation.
intervention type: Drug
intervention name: Vasopressin
description: Vasopressin at dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.
arm group label: Vasopressin
other name: Vasostrict, arginine
intervention type: Drug
intervention name: Normal Saline
description: Normal saline at starting dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.
arm group label: Normal saline
other name: Placebo
criteria: 
gender: All
minimum age: 18 Months
maximum age: 7 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
investigator full name: Jamie Penk
investigator title: Pediatric Cardiologist
mesh term: Pleural Effusion
mesh term: Univentricular Heart
mesh term: Vasopressins
mesh term: Arginine Vasopressin
sharing ipd: No
submitted: August 9, 2023
returned: August 31, 2023