Multi-parameters'Change Process During Dehydration Therapy on Brain Edema Patients.
Alternations of Multi-parameters Including Hemodynamic Concentration and Water Levels During Dehydration Therapy on Brain Edema Patients
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2019
CompletedJuly 24, 2019
July 1, 2019
2 months
January 31, 2019
July 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Δ[HbO2]
changes of oxyhemoglobin concentration
2 weeks
water concentration
water concentration of brain
2 weeks
Secondary Outcomes (2)
intracranial pressure
2 weeks
Δ[Hb]
2 weeks
Study Arms (2)
Mannitol injection
EXPERIMENTALThe participant receive mannitol injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.
Hypertonic saline injection
EXPERIMENTALThe participant receive hypertonic saline of specific concentration injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.
Interventions
Standard mannitol injection to decrease intracranial pressure of patients
Standard Hypertonic saline injection to decrease intracranial pressure of patients
Eligibility Criteria
You may qualify if:
- Patients who had brain edema and need dehydration therapy to decrease intracranial pressure.
You may not qualify if:
- AIDS, Active Hepatitis, Tuberculosis, Syphilis
- Patients who regularly take anticoagulants, antiplatelet drugs
- Anemia, thrombocytopenia
- Hemorrhagic disease like hemophilia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ting Lilead
- Affiliated Hospital of Armed Police Logistics Collegecollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- UNKNOWN
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Fellow
Study Record Dates
First Submitted
January 31, 2019
First Posted
February 4, 2019
Study Start
September 1, 2019
Primary Completion
November 1, 2019
Study Completion
December 11, 2019
Last Updated
July 24, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share