Back to resultsStudy on Cerebral Protection of Dexmedetomidine for Patients With Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Midazolam
Sponsored by
About this trial
This is an interventional prevention trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Xiangya Hospital Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dexmedetomidine treatment group
Midazolam treatment group
Arm Description
Dexmedetomidine will be administrated at a dose of 0.25-0.75 µg/(kg*h) for 5 days
Midazolam will be administrated at a dose of 0.25-0.75 µg/(kg*h) for 5 days
Outcomes
Primary Outcome Measures
Epinephrine
Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Epinephrine
Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Epinephrine
Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Epinephrine
Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Norepinephrine
Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Norepinephrine
Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Norepinephrine
Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Norepinephrine
Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Secondary Outcome Measures
Full Information
NCT ID
NCT04006054
First Posted
June 13, 2019
Last Updated
June 30, 2019
Sponsor
Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT04006054
Brief Title
Study on Cerebral Protection of Dexmedetomidine for Patients With Traumatic Brain Injury
Official Title
Cerebral Protection of Dexmedetomidine Against Paroxysmal Sympathetic Overexcited in Patients With Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine treatment group
Arm Type
Experimental
Arm Description
Dexmedetomidine will be administrated at a dose of 0.25-0.75 µg/(kg*h) for 5 days
Arm Title
Midazolam treatment group
Arm Type
Active Comparator
Arm Description
Midazolam will be administrated at a dose of 0.25-0.75 µg/(kg*h) for 5 days
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
DG
Intervention Description
When the patients who suffered traumatic brain injury are in NICU，Dexmedetomidine is given for sedation about 5 days .
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
MG
Intervention Description
When the patients who suffered traumatic brain injury are in NICU，Midazolam is given for sedation about 5 days .
Primary Outcome Measure Information:
Title
Epinephrine
Description
Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Time Frame
At admission (baseline)
Title
Epinephrine
Description
Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Time Frame
24 hours after injury
Title
Epinephrine
Description
Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Time Frame
48 hours after injury
Title
Epinephrine
Description
Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Time Frame
72 hours after injury
Title
Norepinephrine
Description
Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Time Frame
At admission (baseline)
Title
Norepinephrine
Description
Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Time Frame
24 hours after injury
Title
Norepinephrine
Description
Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Time Frame
48 hours after injury
Title
Norepinephrine
Description
Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Time Frame
72 hours after injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Chen, Doctor
Phone
13517315332
Email
21806497@qq.com
Facility Information:
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingfang Liu, Doctor
Phone
13975800826
Email
1427822007@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study on Cerebral Protection of Dexmedetomidine for Patients With Traumatic Brain Injury
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