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出境医 / 临床实验 / Study on Cerebral Protection of Dexmedetomidine for Patients With Traumatic Brain Injury

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Dexmedetomidine Drug: Midazolam Phase 4

Detailed Description:

Paroxysmal sympathetic hyperactivity (PSH) is a syndrome typically recognized in patients suffering from traumatic brain injury, characterized by paroxysmal increases in sympathetic activity such as elevated heart rate, increased blood pressure and respiratory rate, high temperature, excessive sweating and abnormal motor (posturing) activity.

This prospective study will include patients with traumatic brain injury,who will be divided into two groups, evaluated by the Paroxysmal Sympathetic Hyperactivity-Assessment Measure (PSH-AM). Patients will also be evaluated with head CT.

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Cerebral Protection of Dexmedetomidine Against Paroxysmal Sympathetic Overexcited in Patients With Traumatic Brain Injury
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Dexmedetomidine treatment group
Dexmedetomidine will be administrated at a dose of 0.25-0.75 µg/(kg*h) for 5 days
 Drug: Dexmedetomidine
When the patients who suffered traumatic brain injury are in NICU，Dexmedetomidine is given for sedation about 5 days .
Other Name: DG
Active Comparator: Midazolam treatment group
Midazolam will be administrated at a dose of 0.25-0.75 µg/(kg*h) for 5 days
 Drug: Midazolam
When the patients who suffered traumatic brain injury are in NICU，Midazolam is given for sedation about 5 days .
Other Name: MG
Outcome Measures
Primary Outcome Measures :
  1. Epinephrine [ Time Frame: At admission (baseline) ]
    Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  2. Epinephrine [ Time Frame: 24 hours after injury ]
    Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  3. Epinephrine [ Time Frame: 48 hours after injury ]
    Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  4. Epinephrine [ Time Frame: 72 hours after injury ]
    Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  5. Norepinephrine [ Time Frame: At admission (baseline) ]
    Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  6. Norepinephrine [ Time Frame: 24 hours after injury ]
    Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  7. Norepinephrine [ Time Frame: 48 hours after injury ]
    Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

  8. Norepinephrine [ Time Frame: 72 hours after injury ]
    Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts
Layout table for location contacts
Contact: Xin Chen, Doctor 13517315332 21806497@qq.com

Locations
Layout table for location information
China, Hunan
Xiangya Hospital Central South University Recruiting
Changsha, Hunan, China, 410000
Contact: Jingfang Liu, Doctor    13975800826    1427822007@qq.com   
Sponsors and Collaborators
Xiangya Hospital of Central South University
Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date July 2, 2019
Actual Study Start Date  ICMJE June 6, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2019)
  • Epinephrine [ Time Frame: At admission (baseline) ]
    Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
  • Epinephrine [ Time Frame: 24 hours after injury ]
    Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
  • Epinephrine [ Time Frame: 48 hours after injury ]
    Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
  • Epinephrine [ Time Frame: 72 hours after injury ]
    Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
  • Norepinephrine [ Time Frame: At admission (baseline) ]
    Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
  • Norepinephrine [ Time Frame: 24 hours after injury ]
    Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
  • Norepinephrine [ Time Frame: 48 hours after injury ]
    Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
  • Norepinephrine [ Time Frame: 72 hours after injury ]
    Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on Cerebral Protection of Dexmedetomidine for Patients With Traumatic Brain Injury
Official Title  ICMJE Cerebral Protection of Dexmedetomidine Against Paroxysmal Sympathetic Overexcited in Patients With Traumatic Brain Injury
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.
Detailed Description

Paroxysmal sympathetic hyperactivity (PSH) is a syndrome typically recognized in patients suffering from traumatic brain injury, characterized by paroxysmal increases in sympathetic activity such as elevated heart rate, increased blood pressure and respiratory rate, high temperature, excessive sweating and abnormal motor (posturing) activity.

This prospective study will include patients with traumatic brain injury,who will be divided into two groups, evaluated by the Paroxysmal Sympathetic Hyperactivity-Assessment Measure (PSH-AM). Patients will also be evaluated with head CT.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • Drug: Dexmedetomidine
    When the patients who suffered traumatic brain injury are in NICU，Dexmedetomidine is given for sedation about 5 days .
    Other Name: DG
  • Drug: Midazolam
    When the patients who suffered traumatic brain injury are in NICU，Midazolam is given for sedation about 5 days .
    Other Name: MG
Study Arms  ICMJE
  • Experimental: Dexmedetomidine treatment group
    Dexmedetomidine will be administrated at a dose of 0.25-0.75 µg/(kg*h) for 5 days
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: Midazolam treatment group
    Midazolam will be administrated at a dose of 0.25-0.75 µg/(kg*h) for 5 days
    Intervention: Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2019) 		82
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Severe liver dysfunction (Child-Pugh B or C)
  2. Severe renal dysfunction (serum creatinine > 445 mmol / L or blood urea nitrogen > 20 mmol / L)
  3. Hemodynamic instability when entering the ICU (heart rate <50 beats / min or hypotension, SBP <90mmHg or MAP <65mmHg)
  4. Deaths within 72 hours after entering the ICU
  5. Severe multiple injuries (ISS≥25 points)
  6. Have central nervous system diseases (such as hypoxic ischemic encephalopathy, stroke, brain tumors, etc.)
  7. Allergic to dexmedetomidine or midazolam
  8. Observed with the results of disease interference test (such as pheochromocytoma, etc.)
  9. In pregnancy or lactation
  10. Receiving hypothermia treatment
  11. Are participating in other drug research or clinical trials
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xin Chen, Doctor 13517315332 21806497@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04006054
Other Study ID Numbers  ICMJE 2019040111
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xiangya Hospital of Central South University
Study Sponsor  ICMJE Xiangya Hospital of Central South University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Xiangya Hospital of Central South University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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