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
About this trial
This is an interventional supportive care trial for Hemodynamic Instability focused on measuring Brain edema, dehydration, Noninvasive optical method
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
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
NCT ID
NCT03828032
First Posted
January 31, 2019
Last Updated
July 22, 2019
Sponsor
Ting Li
Collaborators
Affiliated Hospital of Armed Police Logistics College
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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Multi-parameters'Change Process During Dehydration Therapy on Brain Edema Patients.
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