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

Traumatic Brain Injury Clinical Trial

Official title:

Cerebral Protection of Dexmedetomidine Against Paroxysmal Sympathetic Overexcited in Patients With Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04006054
• Other study ID #: 2019040111
• Status: Recruiting
• Phase: Phase 4
• Start date: June 6, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2019
• Source: Xiangya Hospital of Central South University
• Contact: Xin Chen, Doctor
• Phone: 13517315332
• Email: 21806497[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Drug:
• Dexmedetomidine
When the patients who suffered traumatic brain injury are in NICU,Dexmedetomidine is given for sedation about 5 days .
• Midazolam
When the patients who suffered traumatic brain injury are in NICU,Midazolam is given for sedation about 5 days .

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epinephrine	Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.	At admission (baseline)
Primary	Epinephrine	Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.	24 hours after injury
Primary	Epinephrine	Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.	48 hours after injury
Primary	Epinephrine	Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.	72 hours after injury
Primary	Norepinephrine	Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.	At admission (baseline)
Primary	Norepinephrine	Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.	24 hours after injury
Primary	Norepinephrine	Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.	48 hours after injury
Primary	Norepinephrine	Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.	72 hours after injury