Early beta-blockade in severe traumatic brain injury (EBB-TBI)
- Conditions
- Severe traumatic brain injuryNervous System Diseases
- Registration Number
- ISRCTN11038397
- Lead Sponsor
- orth Bristol NHS Trust
- Brief Summary
2023 Protocol article in https://doi.org/10.1007/s12028-023-01755-9 (added 13/06/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38951446/ (added 02/07/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 16
1. Aged =18 years
2. Severe traumatic brain injury (Glasgow Coma Score of 8 or less after resuscitation or prior to intubation)
3. Within 24 h of injury
4. Intracranial pressure monitoring in situ
1. Life or limb-threatening extra-cranial injury (as determined by treating intensivist)
2. Admitted with perceived devastating brain injury for the purposes of prognostication or organ donation
3. Current participation in another clinical trial of an investigational medicinal product or within the preceding 30 days
4. Pregnancy
5. Breastfeeding
6. Hypersensitivity to beta-blockers
7. Cardiogenic shock
8. Decompensated heart failure (New York Heart Association class 4)
9. Untreated sick sinus syndrome or AV nodal conduction disorders including second or third-degree heart block
10. Untreated phaeochromocytoma
11. Acute severe bronchospasm secondary to asthma or chronic obstructive airways disease
12. Severe pulmonary hypertension (mean pulmonary artery pressure >55 mmHg)
13. Prinzmetal’s angina
14. Severe metabolic acidosis (pH <7.1)
15. Use of verapamil within the preceding 48 h
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Continual reassessment method derived maximum tolerated dose of esmolol that will achieve a =15% reduction of heart rate from baseline without compromise of cerebral perfusion pressure in adults within 24 h of severe traumatic brain injury will be assessed using both heart rate recorded by the bedside nurse using standard three-lead ECG monitoring, and cerebral perfusion pressure calculated as the difference between mean arterial pressure (measured via arterial catheter zeroed at the level of the tragus) and intracranial pressure (measured either by parenchymal monitor usually in the non-dominant frontal lobe or external ventricular drain), at 4 days and 6 months
- Secondary Outcome Measures
Name Time Method There are no secondary outcome measures