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

Ting Li

Status: Unknown

Conditions: Hemodynamic Instability; Intracranial Pressure Increase; Water on the Brain

Treatments: Procedure: Hypertonic saline injection; Procedure: Mannitol injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03828032

Brain edema dehydration

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Mannitol injection

Experimental group

Description:

The participant receive mannitol injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.

Treatment:

Procedure: Mannitol injection

Hypertonic saline injection

Experimental group

Description:

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

Treatment:

Procedure: Hypertonic saline injection