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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03828032

Enrollment

Registered

2019-02-04

Start date

2019-09-01

Completion date

2019-12-11

Last updated

2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability, Intracranial Pressure Increase, Water on the Brain

Keywords

Brain edema, dehydration, Noninvasive optical method

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.

Interventions

PROCEDUREMannitol injection

Standard mannitol injection to decrease intracranial pressure of patients

PROCEDUREHypertonic saline injection

Standard Hypertonic saline injection to decrease intracranial pressure of patients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Δ[HbO2]	2 weeks	changes of oxyhemoglobin concentration
water concentration	2 weeks	water concentration of brain

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026