Neuroanesthesia & neurocritical care
Effect of propranolol and clonidine after severe traumatic brain injury: a pilot randomized clinical trial
Primary result · VFDsResult — go to the resultDifference 0.3 days 95% CI - 5.4, 5.8Authors' conclusion
Despite the safety and feasibility of adrenergic blockade with propranolol and clonidine after severe TBI, the intervention did not alter the VFD outcome.
Study context
- Population
- Patients aged 16–64 years with severe traumatic brain injury (TBI) (intracranial hemorrhage and GCS ≤ 8) within 24 h of ICU admissionstopped for futility
- Participants
- 47 patients
- Comparison
- Propranolol and clonidine vs double placebo for 7 days
- Treatmentn = 21
- Placebon = 26reference
- Primary endpoint
- Ventilator-free days (VFDs)
- Follow-up
- 28 days
Methodological detailsphase II, single-centre, double-blinded, pilot, placebo-controlled, planned futility assessment, Dose compliance 99%, Blinding intact; no open-label agents used
- Phase II
- Single-centre
- Double-blinded
- Pilot
- Placebo-controlled
- Planned futility assessment
- Dose compliance 99%
- Blinding intact; no open-label agents used
Primary result
VFDs
Difference
0.3 days
95% CI - 5.4, 5.8
P = 1.0
As reported in the abstract
Secondary outcomes
Features of sympathetic hyperactivity (Clinical Features Scale, Clinical Features Scale (CFS))
- Improvement of features related to sympathetic hyperactivity, between-group mean difference in CFS
- 1.7 points, CI (0.4, 2.9), p = 0.012
Other secondary outcomes (catecholamine levels, hospital LOS, mortality, long-term functional status)
- No between-group differences
Safety
- Dysrhythmia, MI or cardiac arrest — Treatment
- 0 events
Original publication
Effect of propranolol and clonidine after severe traumatic brain injury: a pilot randomized clinical trial. Crit Care. Published 9 June 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →