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

Phase 4

• Conditions: Traumatic Brain Injury
• Interventions: Drug: Dexmedetomidine; Drug: Midazolam

• Registration Number: NCT04006054
• Lead Sponsor: Xiangya Hospital of Central South University

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.

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-06-06
• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-30
• Last Update Submitted: 2019-06-30
• Study First Posted: 2019-07-02
• Last Update Posted: 2019-07-02
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine treatment group	Dexmedetomidine	Dexmedetomidine will be administrated at a dose of 0.25-0.75 µg/(kg\*h) for 5 days
Midazolam treatment group	Midazolam	Midazolam will be administrated at a dose of 0.25-0.75 µg/(kg\*h) for 5 days

Primary Outcome Measures

Name	Time	Method
Epinephrine	72 hours after injury	Epinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.
Norepinephrine	72 hours after injury	Norepinephrine is a hormone secreted by the body.When the patient suffers brain injury, the concentration of Epinephrine will increase significantly.

Trial Locations

Locations (1)

Xiangya Hospital Central South University; 🇨🇳 Changsha, Hunan, China