<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/NCT01668277</url>
  </required_header>
  <id_info>
    <org_study_id>1000026525</org_study_id>
    <nct_id>NCT01668277</nct_id>
  </id_info>
  <brief_title>Effects of Saline on Circulation in Children</brief_title>
  <official_title>Effects of Hypertonic Saline on the Pulmonary Circulation in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulmonary hypertensive crisis is a life-threatening condition, in which the blood pressure in&#xD;
      the pulmonary artery, vein, and capillaries. Infusion of hypertonic saline solutions expand&#xD;
      the circulating volume, thus allowing more blood to flow and reducing pressure in the artery,&#xD;
      vein, and capillaries. Furthermore, infusion of hypertonic saline has been shown to reduce&#xD;
      both systemic and pulmonary vascular resistances in adults. If the pulmonary vascular&#xD;
      resistance decreases more or to the same degree as the systemic resistance, infusion of&#xD;
      hypertonic saline may prove beneficial in the treatment of pulmonary hypertensive crisis. The&#xD;
      primary objective of this study is to investigate how a clinically relevant dose of&#xD;
      hypertonic saline affects the systemic and pulmonary circulations in children undergoing&#xD;
      cardiac catheterization during general anesthesia. This study hypothesizes that an infusion&#xD;
      of hypertonic saline over 10 minutes will reduce the pulmonary vascular resistance more than&#xD;
      the systemic vascular resistance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 2</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pulmonary Vascular Resistance Index</measure>
    <time_frame>Change from Baseline in Pulmonary Vascular Resistance Index after 1 hour</time_frame>
    <description>Pulmonary vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systemic Vascular Resistance Index</measure>
    <time_frame>Change from Baseline in Systemic Vascular Resistance Index after 1 hour</time_frame>
    <description>Systemic vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac Index</measure>
    <time_frame>Change from Baseline in Cardiac Index after 1 hour</time_frame>
    <description>Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Gas</measure>
    <time_frame>Average over 1 hour</time_frame>
    <description>Effect on blood hemoglobin, plasma potassium and sodium, measured on a blood gas analyzer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Volume</measure>
    <time_frame>Average over 1 hour</time_frame>
    <description>Effect on plasma volume calculated from the change in blood hemoglobin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial Natriuretic Peptide</measure>
    <time_frame>Average over 1 hour</time_frame>
    <description>Effect on atrial natriuretic peptide</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Pulmonary Hypertensive Crisis</condition>
  <arm_group>
    <arm_group_label>3 ml/kg 7.2% NaCl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test fluids 7.2% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 ml/kg 0.9% NaCl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The test fluids 0.9% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20 ml/kg 0.9% NaCl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The test fluids 0.9% NaCl 20 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>7.2% NaCl</intervention_name>
    <arm_group_label>3 ml/kg 7.2% NaCl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% NaCl</intervention_name>
    <arm_group_label>20 ml/kg 0.9% NaCl</arm_group_label>
    <arm_group_label>3 ml/kg 0.9% NaCl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children who have had a heart transplant and are scheduled for elective endomyocardial&#xD;
             biopsies during general anaesthesia&#xD;
&#xD;
          -  Age &gt; 2 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Plasma Na &lt; 130 mmol/l or &gt;150 mmol/l&#xD;
&#xD;
          -  Refusal of consent&#xD;
&#xD;
          -  An estimated pulmonary arterial pressure which is greater than or equal to 66% of&#xD;
             systemic blood pressure&#xD;
&#xD;
          -  Children with heart failure (right and/or left), i.e clinical suspicion by either a&#xD;
             cardiologist or an anesthesiologist of inability to tolerate a fluid bolus of 3 ml/kg&#xD;
             7.2% NaCl corresponding to an expansion of the circulatory volume by approximately 9%&#xD;
             (see the section on safety), which is the equivalent of infusion approximately 20&#xD;
             ml/kg 0.9% NaCl over 10 minutes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine Taylor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital For Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Katherine Taylor</investigator_full_name>
    <investigator_title>Staff Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>Pulmonary Hypertensive Crisis</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Hypertonic Saline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertensive Encephalopathy</mesh_term>
  </condition_browse>
  <!-- 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/NCT01668277
org study id: 1000026525
nct id: NCT01668277
lead sponsor: 
has dmc: No
Pulmonary hypertensive crisis is a life-threatening condition, in which the blood pressure in
      the pulmonary artery, vein, and capillaries. Infusion of hypertonic saline solutions expand
      the circulating volume, thus allowing more blood to flow and reducing pressure in the artery,
      vein, and capillaries. Furthermore, infusion of hypertonic saline has been shown to reduce
      both systemic and pulmonary vascular resistances in adults. If the pulmonary vascular
      resistance decreases more or to the same degree as the systemic resistance, infusion of
      hypertonic saline may prove beneficial in the treatment of pulmonary hypertensive crisis. The
      primary objective of this study is to investigate how a clinically relevant dose of
      hypertonic saline affects the systemic and pulmonary circulations in children undergoing
      cardiac catheterization during general anesthesia. This study hypothesizes that an infusion
      of hypertonic saline over 10 minutes will reduce the pulmonary vascular resistance more than
      the systemic vascular resistance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Pulmonary Vascular Resistance Index
time frame: Change from Baseline in Pulmonary Vascular Resistance Index after 1 hour
description: Pulmonary vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.
measure: Systemic Vascular Resistance Index
time frame: Change from Baseline in Systemic Vascular Resistance Index after 1 hour
description: Systemic vascular resistance index, a hemodynamic measurement, will be performed during the cardiac catherization.
measure: Cardiac Index
time frame: Change from Baseline in Cardiac Index after 1 hour
description: Cardiac index, a hemodynamic measurement, will be performed during the cardiac catherization.
measure: Blood Gas
time frame: Average over 1 hour
description: Effect on blood hemoglobin, plasma potassium and sodium, measured on a blood gas analyzer
measure: Plasma Volume
time frame: Average over 1 hour
description: Effect on plasma volume calculated from the change in blood hemoglobin
measure: Atrial Natriuretic Peptide
time frame: Average over 1 hour
description: Effect on atrial natriuretic peptide
arm group label: 3 ml/kg 7.2% NaCl
arm group type: Experimental
description: The test fluids 7.2% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion.
arm group label: 3 ml/kg 0.9% NaCl
arm group type: Active Comparator
description: The test fluids 0.9% NaCl 3 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion.
arm group label: 20 ml/kg 0.9% NaCl
arm group type: Active Comparator
description: The test fluids 0.9% NaCl 20 ml/kg will be infused over 10 min. The hemodynamic parameters will be determined before and after infusion by a cardiologist blinded to the type of infusion.
intervention type: Drug
intervention name: 7.2% NaCl
arm group label: 3 ml/kg 7.2% NaCl
intervention type: Drug
intervention name: 0.9% NaCl
arm group label: 20 ml/kg 0.9% NaCl
arm group label: 3 ml/kg 0.9% NaCl
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: No
last name: Katherine Taylor, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Katherine Taylor
investigator title: Staff Anesthesiologist
mesh term: Hypertensive Encephalopathy