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

Last updated: June 30, 2019
Sponsor: Xiangya Hospital of Central South University
Overall Status: Active - Recruiting

Phase

4

Condition

Traumatic Brain Injury

Memory Loss

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT04006054
2019040111
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 beforeadmission

  6. Have a clear history of head trauma

  7. Non-open traumatic brain injury

Exclusion

Exclusion Criteria:

  1. Severe liver dysfunction (Child-Pugh B or C)

  2. Severe renal dysfunction (serum creatinine > 445 mmol / L or blood urea nitrogen > 20mmol / L)

  3. Hemodynamic instability when entering the ICU (heart rate <50 beats / min orhypotension, 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

Study Design

Total Participants: 82
Study Start date:
June 06, 2019
Estimated Completion Date:
December 30, 2021

Study 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.

Connect with a study center

  • Xiangya Hospital Central South University

    Changsha, Hunan 410000
    China

    Active - Recruiting

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