Study on Cerebral Protection of Dexmedetomidine for Patients With Traumatic Brain Injury

NCT04006054 | Unknown Phase 4

• 1 other identifier: 2019040111
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate whether dexmedetomidine could suppress catecholamine release into peripheral blood to prevent PSH attacks and to achieve neuroprotection.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (8)

• Epinephrine

  Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  At admission (baseline)

• Epinephrine

  Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  24 hours after injury

• Epinephrine

  Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  48 hours after injury

• Epinephrine

  Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  72 hours after injury

• Norepinephrine

  Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  At admission (baseline)

• Norepinephrine

  Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  24 hours after injury

• Norepinephrine

  Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  48 hours after injury

• Norepinephrine

  Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  72 hours after injury

Study Arms (2)

Dexmedetomidine treatment group

EXPERIMENTAL

Dexmedetomidine will be administrated at a dose of 0.25-0.75 µg/(kg\*h) for 5 days

Drug: Dexmedetomidine

Midazolam treatment group

ACTIVE COMPARATOR

Midazolam will be administrated at a dose of 0.25-0.75 µg/(kg\*h) for 5 days

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

When the patients who suffered traumatic brain injury are in NICU，Dexmedetomidine is given for sedation about 5 days .

Also known as: DG

Dexmedetomidine treatment group

Midazolam DRUG

When the patients who suffered traumatic brain injury are in NICU，Midazolam is given for sedation about 5 days .

Also known as: MG

Midazolam treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years
• Moderate or severe traumatic brain injury
• GCS≤12
• Diagnosed by CT
• No catecholamines (such as dopamine, adrenaline, norepinephrine) have been used before admission
• Have a clear history of head trauma
• Non-open traumatic brain injury

You may not qualify if:

• Severe liver dysfunction (Child-Pugh B or C)
• Severe renal dysfunction (serum creatinine \> 445 mmol / L or blood urea nitrogen \> 20 mmol / L)
• Hemodynamic instability when entering the ICU (heart rate \<50 beats / min or hypotension, SBP \<90mmHg or MAP \<65mmHg)
• Deaths within 72 hours after entering the ICU
• Severe multiple injuries (ISS≥25 points)
• Have central nervous system diseases (such as hypoxic ischemic encephalopathy, stroke, brain tumors, etc.)
• Allergic to dexmedetomidine or midazolam
• Observed with the results of disease interference test (such as pheochromocytoma, etc.)
• In pregnancy or lactation
• Receiving hypothermia treatment
• Are participating in other drug research or clinical trials

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Xin Chen, Doctor

CONTACT

13517315332; 21806497@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: July 2, 2019
• Study Start: June 6, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 30, 2021
• Last Updated: July 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)