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

July 22, 2019 updated by: Ting Li

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mannitol injection
The participant receive mannitol injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.
Procedure: Mannitol injection
Standard mannitol injection to decrease intracranial pressure of patients
EXPERIMENTAL: 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.
Procedure: Hypertonic saline injection
Standard Hypertonic saline injection to decrease intracranial pressure of patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Δ[HbO2]
Time Frame: 2 weeks
changes of oxyhemoglobin concentration
2 weeks
water concentration
Time Frame: 2 weeks
water concentration of brain
2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ting Li

Collaborators

Affiliated Hospital of Armed Police Logistics College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2019

Primary Completion (ANTICIPATED)

November 1, 2019

Study Completion (ANTICIPATED)

December 11, 2019

Study Registration Dates

First Submitted

January 31, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (ACTUAL)

February 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Brain edema dehydration

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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