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

Traumatic Brain Injury Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02071407
• Other study ID #: 2014021801
• Status: Recruiting
• Phase: Phase 4
• First received: February 21, 2014
• Last updated: February 24, 2014
• Start date: October 2013

Study information

• Verified date: February 2014
• Source: Subei People's Hospital of Jiangsu Province
• Contact: Ruiqiang Zheng, Doctor
• Phone: 18051060411
• Email: rqzh7[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

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.
• Placebo

Locations

Country	Name	City	State
China	Subei People's Hospital of Jiangsu Province	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Subei People's Hospital of Jiangsu Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	No
Primary	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.	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	No
Secondary	Ramsay score		from the use of midazolam to 72 h after the use for group N2	Yes
Secondary	seizure		from the admission to ICU to 72 h after the admission	Yes
Secondary	one-week mortality		from the admission to ICU to one week after the admission	Yes