Intensive Care Unit, Intracranial Pressure, Mortality, Traumatic Brain Injury (TBI) Patients
Conditions
Brief summary
The role of nonselective beta adrenergic blocker as antistress agent in severe traumatic brain injury
Detailed description
The primary injury occurs at the time of trauma. secondary injury is caused by complications of the primary insult and caused by processes such as hypoxia, cerebral edema and ischemia. Severe traumatic brain injury is associated with increased intracranial pressure, activation of the sympathetic nervous system and catecholamine response and major morbidity and mortality . β-blockade is just one pharmacologic strategy to reduce sympathetic hyperactivity. In the Intensive care unit patients with severe traumatic brain injury associated with restlessness and agitation are frequently sedated and intubated in order to reduce the workload of the brain. This hyperactive response is called sympathetic storming which occurs within 24 hours of brain injury or weeks later . It occurs due to acceleration in sympathetic nervous system activity in the central nervous system which results in loss of cortical control due to downregulation of autonomic balance in the brain injury . A Non-Selective beta-adrenergic antagonist propranolol, is one of the most customarily used treatments in the case of paroxysmal sympathetic hyperactivity.
Interventions
DRUGpropranolol
This group Will receive propranolol intravenously at a dose of 1 mg every 6 h for 7 days, and doses will be held if heart rate less than 60 bpm, mean arterial pressure less than 65 mmHg
DRUGnormal saline IV
This group Will receive 1ml of sterile 0.9% normal saline IV every 6 hours for 7 days
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18and 65 years old * Patients who have Severe traumatic brain injury * Glascow outcome scale ≤ 8
Exclusion criteria
* Patients have pre-existing heart disease. * If there are contraindications to β blocker. * penetrating traumatic brain injury. * pre-injury brain dysfunction. * β-blocker or α2-agonist use before trauma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 7 days | Mortality in severe traumatic brain injury with usage of β blocker |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glascow outcome scale extended | 7 days | Glascow outcome scale extended) consists of 8 categories: Death Persistent vegetative state: awake not aware. Lower severe disability: dependent, require help most of time. Upper severe disability: dependent, can be left alone some time. Iower moderate disability: independent, unable to work. Upper moderate disability: independent, reduced work capacity. Lower good recovery: minor problems that affect daily activities. Upper good recovery: no current problems related to brain injury. |
Countries
Egypt
Contacts
Primary ContactHuda Elkallaf, Resident
Backup ContactHuda Elkallaf, Resident
Outcome results
None listed