Early beta-blockade in severe traumatic brain injury (EBB-TBI)

Early intravenous beta-blockade with esmolol in adults with isolated severe traumatic brain injury: a Phase 2a intervention design study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11038397

Enrollment

Registered

2021-01-07

Start date

2020-11-30

Completion date

Unknown

Last updated

2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe traumatic brain injury Nervous System Diseases

Interventions

The primary objective of this study is a treatment schedule for esmolol. The starting point is a study of patients with sepsis who are receiving multi-organ support with ventilation and vasoactive dru

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026