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Multi-parameters'Change Process During Dehydration Therapy on Brain Edema Patients.

Primary Purpose

Hemodynamic Instability, Water on the Brain, Intracranial Pressure Increase

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mannitol injection
Hypertonic saline injection
Sponsored by
Ting Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemodynamic Instability focused on measuring Brain edema, dehydration, Noninvasive optical method

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Patients who had brain edema and need dehydration therapy to decrease intracranial pressure.

Exclusion Criteria:

  • AIDS, Active Hepatitis, Tuberculosis, Syphilis
  • Patients who regularly take anticoagulants, antiplatelet drugs
  • Anemia, thrombocytopenia
  • Hemorrhagic disease like hemophilia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Mannitol injection

    Hypertonic saline injection

    Arm Description

    The participant receive mannitol injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.

    The participant receive hypertonic saline of specific concentration injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.

    Outcomes

    Primary Outcome Measures

    Δ[HbO2]
    changes of oxyhemoglobin concentration
    water concentration
    water concentration of brain

    Secondary Outcome Measures

    intracranial pressure
    intracranial pressure
    Δ[Hb]
    changes of deoxy-hemoglobin concentration

    Full Information

    First Posted
    January 31, 2019
    Last Updated
    July 22, 2019
    Sponsor
    Ting Li
    Collaborators
    Affiliated Hospital of Armed Police Logistics College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03828032
    Brief Title
    Multi-parameters'Change Process During Dehydration Therapy on Brain Edema Patients.
    Official Title
    Alternations of Multi-parameters Including Hemodynamic Concentration and Water Levels During Dehydration Therapy on Brain Edema Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    November 1, 2019 (Anticipated)
    Study Completion Date
    December 11, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ting Li
    Collaborators
    Affiliated Hospital of Armed Police Logistics College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemodynamic Instability, Water on the Brain, Intracranial Pressure Increase
    Keywords
    Brain edema, dehydration, Noninvasive optical method

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mannitol injection
    Arm Type
    Experimental
    Arm Description
    The participant receive mannitol injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.
    Arm Title
    Hypertonic saline injection
    Arm Type
    Experimental
    Arm 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(s)
    Mannitol injection
    Intervention Description
    Standard mannitol injection to decrease intracranial pressure of patients
    Intervention Type
    Procedure
    Intervention Name(s)
    Hypertonic saline injection
    Intervention Description
    Standard Hypertonic saline injection to decrease intracranial pressure of patients
    Primary Outcome Measure Information:
    Title
    Δ[HbO2]
    Description
    changes of oxyhemoglobin concentration
    Time Frame
    2 weeks
    Title
    water concentration
    Description
    water concentration of brain
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    intracranial pressure
    Description
    intracranial pressure
    Time Frame
    2 weeks
    Title
    Δ[Hb]
    Description
    changes of deoxy-hemoglobin concentration
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • Patients who had brain edema and need dehydration therapy to decrease intracranial pressure. Exclusion Criteria: AIDS, Active Hepatitis, Tuberculosis, Syphilis Patients who regularly take anticoagulants, antiplatelet drugs Anemia, thrombocytopenia Hemorrhagic disease like hemophilia

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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