<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/NCT04465565</url>
  </required_header>
  <id_info>
    <org_study_id>RMC068119ctil</org_study_id>
    <nct_id>NCT04465565</nct_id>
  </id_info>
  <brief_title>Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test</brief_title>
  <official_title>Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test- Randomized, 2 Arms, Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The diagnosis of Growth Hormone deficiency in childhood requires the performance of an&#xD;
      artificial pharmacological stimulation tests. There are number of substances that increase&#xD;
      the secretion of growth hormone, among them Clonidine and Arginine. One of the possible side&#xD;
      effects of both Clonidine and Arginine is a reduction in the blood pressure due to a&#xD;
      decreased heart output and declined contraction of peripheral blood vessels. In cases where&#xD;
      values of blood pressure at the end of the test are not recovered after two sessions of 15&#xD;
      minutes of physical activity, the patient is treated with I. V of 9%NORMAL SALINE (0. 20cc&#xD;
      /Kg) administrated over 30-60 minutes.&#xD;
&#xD;
      The aim of the proposed study is to test whether administration of fluids during the combined&#xD;
      Growth Hormone stimulation test Clonidine-Arginine will help in the recovery process from the&#xD;
      test (blood pressure &gt; 90/50 mmHg after performing physical activity defined as 15-minutes&#xD;
      hike in two consecutive sessions). The study design will be randomized, controlled, 2 arms&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI decision&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2020</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2022</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>Randomized, 2 arms, controlled study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average blood pressure</measure>
    <time_frame>Time 180 mnutes- at time of discharging the participant</time_frame>
    <description>Average blood pressure ( 3 measurements in 5 minutes intervals)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average blood pressure</measure>
    <time_frame>Time 0- prior to initiating the Growth Hormone test</time_frame>
    <description>Average blood pressure ( 3 measurements in 5 minutes intervals)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average blood pressure</measure>
    <time_frame>Time 90 minutes after completing the Arginine adminstration</time_frame>
    <description>Average blood pressure ( 3 measurements in 5 minutes intervals)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average blood pressure</measure>
    <time_frame>Time 150 minutes after completing the Arginine adminstration</time_frame>
    <description>Average blood pressure ( 3 measurements in 5 minutes intervals)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time elapsed between completing the Growth Hormone test until participant is allowed to go home</measure>
    <time_frame>Time 180 minutes-at time of discharging the participant (after measuring blood pressure &gt; 50/90mm/Hg)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Growth Hormone Deficiency</condition>
  <arm_group>
    <arm_group_label>Intravenous fluid administration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will include 20 children who received Testoviron or Estrofem prior to the the stimulation test and 40 children who did not receive preparation prior to the stimulation test. Participants in this arm will be treated with I. V of 9%NORMAL SALINE (0. 20cc /Kg) administrated over 60 minutes. The fluids treatment will be initiated 90 minutes after the stimulation test will begin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This arm will include 20 children who received Testoviron or Estrofem prior to the the stimulation test and 40 children who did not receive preparation prior to the stimulation test. Participants in this arm will not receive fluids intravenously during the stimulation test, unless it will be required due to safety reasons</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>9% Sodium Chloride (NaCl) IV</intervention_name>
    <description>9% Sodiun Chloride (NaCl) ( 20cc/kg) adminstrated intravenously</description>
    <arm_group_label>Intravenous fluid administration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children referred to combined Arginine- Conidine Growth Hormone stimulation test&#xD;
&#xD;
          -  Girls: 7-14 years old and Boys: 7-16 years old&#xD;
&#xD;
          -  Weight&gt;20 kg&#xD;
&#xD;
          -  Normal thyroid function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI over percentile 85&#xD;
&#xD;
          -  Genetic syndromes or chromosomal disorders&#xD;
&#xD;
          -  Steroid treatment&#xD;
&#xD;
          -  Renal failure&#xD;
&#xD;
          -  Heart failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moshe Phillip, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schneider Children's Medical Center, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schneider Children's Medical Center of Israel</name>
      <address>
        <city>Petach-Tikva</city>
        <zip>4920235</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>February 21, 2022</last_update_submitted>
  <last_update_submitted_qc>February 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Growth Hormone stimulation tests</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04465565
org study id: RMC068119ctil
nct id: NCT04465565
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The diagnosis of Growth Hormone deficiency in childhood requires the performance of an
      artificial pharmacological stimulation tests. There are number of substances that increase
      the secretion of growth hormone, among them Clonidine and Arginine. One of the possible side
      effects of both Clonidine and Arginine is a reduction in the blood pressure due to a
      decreased heart output and declined contraction of peripheral blood vessels. In cases where
      values of blood pressure at the end of the test are not recovered after two sessions of 15
      minutes of physical activity, the patient is treated with I. V of 9%NORMAL SALINE (0. 20cc
      /Kg) administrated over 30-60 minutes.

      The aim of the proposed study is to test whether administration of fluids during the combined
      Growth Hormone stimulation test Clonidine-Arginine will help in the recovery process from the
      test (blood pressure > 90/50 mmHg after performing physical activity defined as 15-minutes
      hike in two consecutive sessions). The study design will be randomized, controlled, 2 arms
      study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, 2 arms, controlled study
primary purpose: Supportive Care
masking: None (Open Label)
measure: Average blood pressure
time frame: Time 180 mnutes- at time of discharging the participant
description: Average blood pressure ( 3 measurements in 5 minutes intervals)
measure: Average blood pressure
time frame: Time 0- prior to initiating the Growth Hormone test
description: Average blood pressure ( 3 measurements in 5 minutes intervals)
measure: Average blood pressure
time frame: Time 90 minutes after completing the Arginine adminstration
description: Average blood pressure ( 3 measurements in 5 minutes intervals)
measure: Average blood pressure
time frame: Time 150 minutes after completing the Arginine adminstration
description: Average blood pressure ( 3 measurements in 5 minutes intervals)
measure: Time elapsed between completing the Growth Hormone test until participant is allowed to go home
time frame: Time 180 minutes-at time of discharging the participant (after measuring blood pressure > 50/90mm/Hg)
arm group label: Intravenous fluid administration
arm group type: Experimental
description: This arm will include 20 children who received Testoviron or Estrofem prior to the the stimulation test and 40 children who did not receive preparation prior to the stimulation test. Participants in this arm will be treated with I. V of 9%NORMAL SALINE (0. 20cc /Kg) administrated over 60 minutes. The fluids treatment will be initiated 90 minutes after the stimulation test will begin
arm group label: Control Group
arm group type: No Intervention
description: This arm will include 20 children who received Testoviron or Estrofem prior to the the stimulation test and 40 children who did not receive preparation prior to the stimulation test. Participants in this arm will not receive fluids intravenously during the stimulation test, unless it will be required due to safety reasons
intervention type: Procedure
intervention name: 9% Sodium Chloride (NaCl) IV
description: 9% Sodiun Chloride (NaCl) ( 20cc/kg) adminstrated intravenously
arm group label: Intravenous fluid administration
criteria: 
gender: All
minimum age: 7 Years
maximum age: 16 Years
healthy volunteers: No
last name: Moshe Phillip, Prof
role: Principal Investigator
affiliation: Schneider Children's Medical Center, Israel
facility: 
country: Israel
responsible party type: Sponsor
sharing ipd: No