Back to resultsA Clinical Trial of the Effect of Midazolam on the Cerebral Metabolism and Inflammatory Response in Patients With Moderate and Severe Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Midazolam
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, sedation, midazolam
Eligibility Criteria
Inclusion Criteria:
- Aged 18 or older;
- Hospitalized in ICU within 6 hours after the injury or after the operation;
- Traumatic brain injury is confirmed by computed tomography scan or magnetic resonance imaging, Glasgow Coma Scale is 3 to 12, and the patient should meet the diagnostic standard of severe traumatic brain injury;
- Informed consent is obtained.
Exclusion Criteria:
- Aged less than 18;
- Death is expected in 24 hours;
- History of neurological disease or history of drug abuse which may affect the outcome of the study;
- Failed to obtain Informed consent.
Sites / Locations
- Subei People's Hospital of Jiangsu ProvinceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
N1(traditional treatment group)
N2(midazolam group)
Arm Description
Patients in group N1 are treated with basic therapeutic measures which include reducing intracranial pressure with mannitol, hemostasis, acid inhibition, anti-infection, nutrition support and control of blood glucose, blood pressure and body temprature.
Patients in group N2 was treated with intravenous infusion of midazolam on the basis of basic treatment measures which include reducing intracranial pressure with mannitol, hemostasis, acid inhibition, anti-infection, nutrition support and control of blood glucose, blood pressure and body temprature.
Outcomes
Primary Outcome Measures
Cerebral metabolic parameters
N1 group: blood samples will be collected when the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission
N2 group: blood samples will be collected before the use of midazolam, 24 h, 48 h and 72 h after the use
Blood sample will be collected every time from the radial artery and the jugular bulb separately. The blood sample will be used for blood gas analysis
Detail parameters by blood test: levels of lactic acid, oxygen saturation(SaO2), partial pressure of oxygen(Pa02), jugular bulb venous oxygen saturation(SjvO2), jugular bulb oxygen partial pressure(PjvO2), hemoglobin(Hb)
Calculated parameters: arterial oxygen content(Ca02), jugular venous oxygen saturation (SjvO2), arterial venous oxygen content difference(Da-jvO2), cerebral extraction of oxygen(CERO2), Lactate differences between jugular and arterial blood(AVDL) and Cerebral lactate acid production(CLP)
Parameters of intracranial inflammatory response
N1: blood samples and cerebrospinal fluid are collected when the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission
N2: blood samples and cerebrospinal fluid are collected before the use of midazolam, 24 h, 48 h and 72 h after the use
every time, 3 ml blood sample will be collected from the jugular bulb and 2 ml cerebrospinal fluid will be collected at the corresponding time
The blood sample will be anticoagulated by EDTA and then it will be centrifuged at 3000 r/min for 10 minutes within 30 minutes from the collection. The supernatant liquid will be stored in the freezer at -70℃.
The cerebrospinal fluid centrifuged at 3000 r/min for 10 minutes, and then the supernatant liquid will be stored in the freezer at -80℃.
Detail parameters: sFkn and IL-6 levels of the blood sample and CSF will be tested 2 times by ELISA and then take the average.
Secondary Outcome Measures
Ramsay score
seizure
one-week mortality
Full Information
NCT ID
NCT02071407
First Posted
February 21, 2014
Last Updated
February 24, 2014
Sponsor
Subei People's Hospital of Jiangsu Province
1. Study Identification
Unique Protocol Identification Number
NCT02071407
Brief Title
A Clinical Trial of the Effect of Midazolam on the Cerebral Metabolism and Inflammatory Response in Patients With Moderate and Severe Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Subei People's Hospital of Jiangsu Province
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To explore the cerebral protective effect of midazolam in patients with traumatic brain injury, we will collect blood samples from patients treated with or without midazolam when the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission before the use of midazolam for patients in group N1, and before the patient is treated with midazolam, 24 h， 48 h, 72 h after the use of midazolam for patients in group N2. Parameters of cerebral metabolism and inflammatory response will be obtained from the blood samples or the cerebrospinal fluid. With the aforementioned parameters, the relationship between clinical outcome and cerebral metabolism and inflammatory response will be detected with statistical method.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury, sedation, midazolam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
N1(traditional treatment group)
Arm Type
Placebo Comparator
Arm Description
Patients in group N1 are treated with basic therapeutic measures which include reducing intracranial pressure with mannitol, hemostasis, acid inhibition, anti-infection, nutrition support and control of blood glucose, blood pressure and body temprature.
Arm Title
N2(midazolam group)
Arm Type
Experimental
Arm Description
Patients in group N2 was treated with intravenous infusion of midazolam on the basis of basic treatment measures which include reducing intracranial pressure with mannitol, hemostasis, acid inhibition, anti-infection, nutrition support and control of blood glucose, blood pressure and body temprature.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
For patients allocated into group N2, 2 mg midazolam will be injected intravenously, and then it will be given at 0.05-0.1 mg/(kg·h) by intravenous infusion. If a surgery is needed, infusion of midazolam will begin 3 hours after the operation and continue for at least 72 hours. During the sedation with midazolam, BIS should be kept at 60 to 80.
Morphine can be used to supply adequate analgesia.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Cerebral metabolic parameters
Description
N1 group: blood samples will be collected when the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission
N2 group: blood samples will be collected before the use of midazolam, 24 h, 48 h and 72 h after the use
Blood sample will be collected every time from the radial artery and the jugular bulb separately. The blood sample will be used for blood gas analysis
Detail parameters by blood test: levels of lactic acid, oxygen saturation(SaO2), partial pressure of oxygen(Pa02), jugular bulb venous oxygen saturation(SjvO2), jugular bulb oxygen partial pressure(PjvO2), hemoglobin(Hb)
Calculated parameters: arterial oxygen content(Ca02), jugular venous oxygen saturation (SjvO2), arterial venous oxygen content difference(Da-jvO2), cerebral extraction of oxygen(CERO2), Lactate differences between jugular and arterial blood(AVDL) and Cerebral lactate acid production(CLP)
Time Frame
from the admission to ICU to 72 h after the admission for Group N1 and before the use of midazolam to 72 h after the use for group N2
Title
Parameters of intracranial inflammatory response
Description
N1: blood samples and cerebrospinal fluid are collected when the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission
N2: blood samples and cerebrospinal fluid are collected before the use of midazolam, 24 h, 48 h and 72 h after the use
every time, 3 ml blood sample will be collected from the jugular bulb and 2 ml cerebrospinal fluid will be collected at the corresponding time
The blood sample will be anticoagulated by EDTA and then it will be centrifuged at 3000 r/min for 10 minutes within 30 minutes from the collection. The supernatant liquid will be stored in the freezer at -70℃.
The cerebrospinal fluid centrifuged at 3000 r/min for 10 minutes, and then the supernatant liquid will be stored in the freezer at -80℃.
Detail parameters: sFkn and IL-6 levels of the blood sample and CSF will be tested 2 times by ELISA and then take the average.
Time Frame
from the admission to ICU to 72 h after the admission for Group N1 and before the use of midazolam to 72 h after the use for group N2
Secondary Outcome Measure Information:
Title
Ramsay score
Time Frame
from the use of midazolam to 72 h after the use for group N2
Title
seizure
Time Frame
from the admission to ICU to 72 h after the admission
Title
one-week mortality
Time Frame
from the admission to ICU to one week after the admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 or older;
Hospitalized in ICU within 6 hours after the injury or after the operation;
Traumatic brain injury is confirmed by computed tomography scan or magnetic resonance imaging, Glasgow Coma Scale is 3 to 12, and the patient should meet the diagnostic standard of severe traumatic brain injury;
Informed consent is obtained.
Exclusion Criteria:
Aged less than 18;
Death is expected in 24 hours;
History of neurological disease or history of drug abuse which may affect the outcome of the study;
Failed to obtain Informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruiqiang Zheng, Doctor
Phone
18051060411
Email
rqzh7@yahoo.com.cn
Facility Information:
Facility Name
Subei People's Hospital of Jiangsu Province
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruiqiang Zheng, Doctor
Phone
18051060411
Email
rqzh7@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Ruiqiang Zheng, Doctor
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of the Effect of Midazolam on the Cerebral Metabolism and Inflammatory Response in Patients With Moderate and Severe Traumatic Brain Injury
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