Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Trial of the Effect of Midazolam on the Cerebral Metabolism and Inflammatory Response in Patients With Moderate and Severe Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02071407
Recruitment Status : Unknown
Verified February 2014 by Subei People's Hospital of Jiangsu Province.
Recruitment status was:  Recruiting
First Posted : February 25, 2014
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):
Subei People's Hospital of Jiangsu Province

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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : October 2013
Estimated Primary Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: N1(traditional treatment group)
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.
Drug: Placebo
Experimental: N2(midazolam group)
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.
Drug: Midazolam

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.





Primary Outcome Measures :
  1. Cerebral metabolic parameters [ 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 ]

    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)


  2. Parameters of intracranial inflammatory response [ 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 ]

    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 :
  1. Ramsay score [ Time Frame: from the use of midazolam to 72 h after the use for group N2 ]
  2. seizure [ Time Frame: from the admission to ICU to 72 h after the admission ]
  3. one-week mortality [ Time Frame: from the admission to ICU to one week after the admission ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071407


Contacts
Layout table for location contacts
Contact: Ruiqiang Zheng, Doctor 18051060411 rqzh7@yahoo.com.cn

Locations
Layout table for location information
China, Jiangsu
Subei People's Hospital of Jiangsu Province Recruiting
Yangzhou, Jiangsu, China, 225001
Contact: Ruiqiang Zheng, Doctor    18051060411    rqzh7@yahoo.com.cn   
Principal Investigator: Ruiqiang Zheng, Doctor         
Sponsors and Collaborators
Subei People's Hospital of Jiangsu Province
Layout table for additonal information
Responsible Party: Subei People's Hospital of Jiangsu Province
ClinicalTrials.gov Identifier: NCT02071407    
Other Study ID Numbers: 2014021801
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014
Keywords provided by Subei People's Hospital of Jiangsu Province:
traumatic brain injury
sedation
midazolam
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action