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NCT03828032 Clinical Trial

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

Hemodynamic Instability Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03828032
Other study ID # Brain edema dehydration
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date December 11, 2019

Study information
Verified date July 2019
Source Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date December 11, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Mannitol injection
Standard mannitol injection to decrease intracranial pressure of patients
• Hypertonic saline injection
Standard Hypertonic saline injection to decrease intracranial pressure of patients

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Ting Li Affiliated Hospital of Armed Police Logistics College

Outcome
Type Measure Description Time frame Safety issue
Primary ?[HbO2] changes of oxyhemoglobin concentration 2 weeks
Primary water concentration water concentration of brain 2 weeks
Secondary intracranial pressure intracranial pressure 2 weeks
Secondary ?[Hb] changes of deoxy-hemoglobin concentration 2 weeks
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