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

Not Applicable

• Conditions: Water on the Brain; Hemodynamic Instability; Intracranial Pressure Increase
• Interventions: Procedure: Hypertonic saline injection; Procedure: Mannitol injection

• Registration Number: NCT03828032
• Lead Sponsor: Ting Li

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.

Study Timeline

• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-24
• Study Start: 2019-09-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertonic saline injection	Hypertonic saline injection	The participant receive hypertonic saline of specific concentration injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.
Mannitol injection	Mannitol injection	The participant receive mannitol injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.

Primary Outcome Measures

Name	Time	Method
water concentration	2 weeks	water concentration of brain
Δ[HbO2]	2 weeks	changes of oxyhemoglobin concentration

Secondary Outcome Measures

Name	Time	Method
intracranial pressure	2 weeks	intracranial pressure
Δ[Hb]	2 weeks	changes of deoxy-hemoglobin concentration