<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/NCT03828032</url>
  </required_header>
  <id_info>
    <org_study_id>Brain edema dehydration</org_study_id>
    <nct_id>NCT03828032</nct_id>
  </id_info>
  <brief_title>Multi-parameters'Change Process During Dehydration Therapy on Brain Edema Patients.</brief_title>
  <official_title>Alternations of Multi-parameters Including Hemodynamic Concentration and Water Levels During Dehydration Therapy on Brain Edema Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ting Li</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Affiliated Hospital of Armed Police Logistics College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aims to investigate the inner mechanism during different dehydration therapies&#xD;
      such as mannitol injection and hypertonic saline. The investigators used a self-made near&#xD;
      infrared spectroscopy (NIRS) instrument to monitor the physiological changes noninvasively&#xD;
      including oxyhemoglobin ([HbO2]), deoxy-hemoglobin ([Hb]), the derived change in blood volume&#xD;
      ([tHb]) and water concentration on the forehead of brain edema patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cerebral edema, as an acute head injury along with high intracranial pressure, has been of&#xD;
      great interest over decades in clinical neurosurgery research. Dehydration therapy is a&#xD;
      common clinical method to decrease intracranial pressure. This study aims to investigate the&#xD;
      inner mechanism during different dehydration therapies such as mannitol injection and&#xD;
      hypertonic saline. The investigators used a self-made near infrared spectroscopy (NIRS)&#xD;
      instrument to monitor the physiological changes noninvasively including oxyhemoglobin&#xD;
      ([HbO2]), deoxy-hemoglobin ([Hb]), the derived change in blood volume ([tHb]) and water&#xD;
      concentration on the forehead of brain edema patients. Then the investigators compared the&#xD;
      changes process of multiple physiological parameters during different dehydration therapies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2019</start_date>
  <completion_date type="Anticipated">December 11, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2019</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Δ[HbO2]</measure>
    <time_frame>2 weeks</time_frame>
    <description>changes of oxyhemoglobin concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>water concentration</measure>
    <time_frame>2 weeks</time_frame>
    <description>water concentration of brain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intracranial pressure</measure>
    <time_frame>2 weeks</time_frame>
    <description>intracranial pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Δ[Hb]</measure>
    <time_frame>2 weeks</time_frame>
    <description>changes of deoxy-hemoglobin concentration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Hemodynamic Instability</condition>
  <condition>Water on the Brain</condition>
  <condition>Intracranial Pressure Increase</condition>
  <arm_group>
    <arm_group_label>Mannitol injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participant receive mannitol injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypertonic saline injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participant receive hypertonic saline of specific concentration injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mannitol injection</intervention_name>
    <description>Standard mannitol injection to decrease intracranial pressure of patients</description>
    <arm_group_label>Mannitol injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hypertonic saline injection</intervention_name>
    <description>Standard Hypertonic saline injection to decrease intracranial pressure of patients</description>
    <arm_group_label>Hypertonic saline injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Patients who had brain edema and need dehydration therapy to decrease intracranial&#xD;
        pressure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AIDS, Active Hepatitis, Tuberculosis, Syphilis&#xD;
&#xD;
          -  Patients who regularly take anticoagulants, antiplatelet drugs&#xD;
&#xD;
          -  Anemia, thrombocytopenia&#xD;
&#xD;
          -  Hemorrhagic disease like hemophilia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Ting Li</investigator_full_name>
    <investigator_title>Fellow</investigator_title>
  </responsible_party>
  <keyword>Brain edema</keyword>
  <keyword>dehydration</keyword>
  <keyword>Noninvasive optical method</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Edema</mesh_term>
    <mesh_term>Intracranial Hypertension</mesh_term>
    <mesh_term>Dehydration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mannitol</mesh_term>
  </intervention_browse>
  <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/NCT03828032
org study id: Brain edema dehydration
nct id: NCT03828032
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the inner mechanism during different dehydration therapies
      such as mannitol injection and hypertonic saline. The investigators used a self-made near
      infrared spectroscopy (NIRS) instrument to monitor the physiological changes noninvasively
      including oxyhemoglobin ([HbO2]), deoxy-hemoglobin ([Hb]), the derived change in blood volume
      ([tHb]) and water concentration on the forehead of brain edema patients.
Cerebral edema, as an acute head injury along with high intracranial pressure, has been of
      great interest over decades in clinical neurosurgery research. Dehydration therapy is a
      common clinical method to decrease intracranial pressure. This study aims to investigate the
      inner mechanism during different dehydration therapies such as mannitol injection and
      hypertonic saline. The investigators used a self-made near infrared spectroscopy (NIRS)
      instrument to monitor the physiological changes noninvasively including oxyhemoglobin
      ([HbO2]), deoxy-hemoglobin ([Hb]), the derived change in blood volume ([tHb]) and water
      concentration on the forehead of brain edema patients. Then the investigators compared the
      changes process of multiple physiological parameters during different dehydration therapies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Δ[HbO2]
time frame: 2 weeks
description: changes of oxyhemoglobin concentration
measure: water concentration
time frame: 2 weeks
description: water concentration of brain
measure: intracranial pressure
time frame: 2 weeks
description: intracranial pressure
measure: Δ[Hb]
time frame: 2 weeks
description: changes of deoxy-hemoglobin concentration
arm group label: Mannitol injection
arm group type: Experimental
description: The participant receive mannitol injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.
arm group label: Hypertonic saline injection
arm group type: Experimental
description: The participant receive hypertonic saline of specific concentration injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.
intervention type: Procedure
intervention name: Mannitol injection
description: Standard mannitol injection to decrease intracranial pressure of patients
arm group label: Mannitol injection
intervention type: Procedure
intervention name: Hypertonic saline injection
description: Standard Hypertonic saline injection to decrease intracranial pressure of patients
arm group label: Hypertonic saline injection
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Ting Li
investigator title: Fellow
mesh term: Brain Edema
mesh term: Intracranial Hypertension
mesh term: Dehydration
mesh term: Mannitol
sharing ipd: No