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

Study Overview
=================
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.

Official Title
-----------------
Alternations of Multi-parameters Including Hemodynamic Concentration and Water Levels During Dehydration Therapy on Brain Edema Patients

Conditions
-----------------
Hemodynamic Instability, Water on the Brain, Intracranial Pressure Increase

Intervention / Treatment
-----------------
* Procedure: Mannitol injection
* Procedure: Hypertonic saline injection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mannitol injection<br>The participant receive mannitol injection to decrease intracranial pressure in the ward with optical probes on his/her forehead. | Procedure: Mannitol injection<br>* Standard mannitol injection to decrease intracranial pressure of patients<br>|
| Experimental: Hypertonic saline injection<br>The participant receive hypertonic saline of specific concentration injection to decrease intracranial pressure in the ward with optical probes on his/her forehead. | Procedure: Hypertonic saline injection<br>* Standard Hypertonic saline injection to decrease intracranial pressure of patients<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Δ[HbO2] | changes of oxyhemoglobin concentration | 2 weeks | 
| water concentration | water concentration of brain | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intracranial pressure | intracranial pressure | 2 weeks | 
| Δ[Hb] | changes of deoxy-hemoglobin concentration | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain edema, dehydration, Noninvasive optical method