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

NCT ID: NCT03828032

Last Updated: 2019-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2019-12-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodynamic Instability Water on the Brain Intracranial Pressure Increase

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mannitol injection

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

Group Type EXPERIMENTAL

Mannitol injection

Intervention Type PROCEDURE

Standard mannitol injection to decrease intracranial pressure of patients

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.

Group Type EXPERIMENTAL

Hypertonic saline injection

Intervention Type PROCEDURE

Standard Hypertonic saline injection to decrease intracranial pressure of patients

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mannitol injection

Standard mannitol injection to decrease intracranial pressure of patients

Intervention Type PROCEDURE

Hypertonic saline injection

Standard Hypertonic saline injection to decrease intracranial pressure of patients

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Affiliated Hospital of Armed Police Logistics College

UNKNOWN

Sponsor Role collaborator

Ting Li

UNKNOWN

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ting Li

Fellow

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Brain edema dehydration

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mannitol Brain Relaxation Effect
NCT02168075 UNKNOWN NA