Hemodynamic InstabilityNCT03828032

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

A study testing Mannitol injection and Hypertonic saline injection in people with Hemodynamic Instability and Water on the Brain, run by Ting Li.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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])… Read more about this study

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Hemodynamic Instability, Water on the Brain, Intracranial Pressure Increase
What is being tested?: Mannitol injection and Hypertonic saline injection
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: 1 Sep 2019to 11 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who had brain edema and need dehydration therapy to decrease intracranial pressure.

Who cannot join

AIDS, Active Hepatitis, Tuberculosis, Syphilis
Patients who regularly take anticoagulants, antiplatelet drugs
Anemia, thrombocytopenia
Hemorrhagic disease like hemophilia

About this study

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

Read the 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.

Conditions: Hemodynamic Instability, Water on the Brain, Intracranial Pressure Increase
Being tested: Mannitol injection, Hypertonic saline injection
Keywords: Brain edema, dehydration, Noninvasive optical method
Medical subject headings: Hydrocephalus, Intracranial Hypertension, Brain Edema, Dehydration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mannitol injectionProcedure or surgery
Standard mannitol injection to decrease intracranial pressure of patients
Hypertonic saline injectionProcedure or surgery
Standard Hypertonic saline injection to decrease intracranial pressure of patients

Study groups in NCT03828032
Study group	Role	What they receive
Mannitol injection	Experimental	The participant receive mannitol injection to decrease intracranial pressure in the ward with optical probes on his/her forehead. Receives: Procedure: Mannitol injection
Hypertonic saline injection	Experimental	The participant receive hypertonic saline of specific concentration injection to decrease intracranial pressure in the ward with optical probes on his/her forehead. Receives: Procedure: Hypertonic saline injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Δ[HbO2]
changes of oxyhemoglobin concentration
Measured: 2 weeks
water concentration
water concentration of brain
Measured: 2 weeks

Secondary outcomes (2)

intracranial pressure
intracranial pressure
Measured: 2 weeks
Δ[Hb]
changes of deoxy-hemoglobin concentration
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201911 Dec 2019

First posted4 Feb 2019
Study start1 Sep 2019 (estimated)
Primary completion1 Nov 2019 (estimated)
Study completion11 Dec 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03828032
Sponsor's protocol ID: Brain edema dehydration
Status last verified: Jul 2019
First submitted: 31 Jan 2019
Last updated: 24 Jul 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alternations of Multi-parameters Including Hemodynamic Concentration and Water Levels During Dehydration Therapy on Brain Edema Patients
ClinicalTrials.gov ID: NCT03828032
Acronym / sponsor ID: Brain edema dehydration
Conditions: Hemodynamic Instability, Water on the Brain, Intracranial Pressure Increase
Keywords: Brain edema, dehydration, Noninvasive optical method
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Ting Li
Collaborators: Affiliated Hospital of Armed Police Logistics College
Study start: 1 Sep 2019 (estimated)
Primary completion: 1 Nov 2019 (estimated)
Study completion: 11 Dec 2019 (estimated)
First posted: 4 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mannitol injection	Experimental	Procedure: Mannitol injectionThe participant receive mannitol injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.
Hypertonic saline injection	Experimental	Procedure: Hypertonic saline injectionThe participant receive hypertonic saline of specific concentration injection to decrease intracranial pressure in the ward with optical probes on his/her forehead.

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients who had brain edema and need dehydration therapy to decrease intracranial pressure.

Key exclusion criteria (4 listed)

AIDS, Active Hepatitis, Tuberculosis, Syphilis
Patients who regularly take anticoagulants, antiplatelet drugs
Anemia, thrombocytopenia
Hemorrhagic disease like hemophilia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mannitol injectionStandard mannitol injection to decrease intracranial pressure of patients	Procedure or surgery	Mannitol injection
Hypertonic saline injectionStandard Hypertonic saline injection to decrease intracranial pressure of patients	Procedure or surgery	Hypertonic saline injection

Primary outcome

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

2 secondary outcomes

intracranial pressure
Time frame: 2 weeks
Δ[Hb]
Time frame: 2 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
Individual participant dataSharing planned: No

Related trials for Hemodynamic Instability

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Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
CPAP Ventilation, Sedation
RecruitingObservational study
Machine Learning-Assisted Management of Intraoperative Hypotension for Personalized Treatment
Intraoperative Hypotension, Perioperative Care
Not yet recruitingObservational study
Development and Internal Validation of a Multimodal Prediction Score for Early Hemodynamic Deterioration in Adult Polytrauma Patients
Multiple Trauma, Polytrauma
RecruitingObservational study
Internal Jugular Vein Ultrasound and Acute Kidney Injury After Abdominal Surgery
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Not yet recruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Mannitol injection and Hypertonic saline injection in people with Hemodynamic Instability and Water on the Brain, run by Ting Li.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Δ[HbO2] (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03828032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.