![]() These findings have resulted in an increase in β-blocker use in our institution to greater than 40% in young, severe TBI patients. Prior retrospective studies, including two from our group, link adrenergic blockade to survival after severe TBI, possibly mediated by dampened sympathetic hyperactivity. This increased catecholamine response is predictive of length of stay, mechanical ventilation, neurologic outcome, and mortality. Severe traumatic brain injury (TBI) is associated with increased intracranial pressure, activation of the sympathetic nervous system and catecholamine response, and major morbidity and mortality. Given the widespread use of these agents in TBI care, a multi-center investigation is warranted to determine whether adrenergic blockade is of therapeutic benefit in patients with severe TBI. Conclusionĭespite the safety and feasibility of adrenergic blockade with propranolol and clonidine after severe TBI, the intervention did not alter the VFD outcome. Other than improvement of features related to sympathetic hyperactivity (mean difference in Clinical Features Scale (CFS) 1.7 points, CI (0.4, 2.9), p = 0.012), there were no between-group differences in the secondary outcomes. There was no significant difference in VFDs between treatment and control groups. The study was stopped for futility after enrolling 47 patients (26 placebo, 21 treatment), per a priori stopping rules. No treatment patient experienced dysrhythmia, myocardial infarction, or cardiac arrest. Resultsĭose compliance was 99%, blinding was intact, and no open-label agents were used. A planned futility assessment was performed mid-study. Secondary outcomes included catecholamine levels, hospital length of stay, mortality, and long-term functional status. The primary outcome was ventilator-free days (VFDs) at 28 days. Patients received propranolol and clonidine or double placebo for 7 days. This phase II, single-center, double-blinded, pilot randomized placebo-controlled trial included patients aged 16–64 years with severe TBI (intracranial hemorrhage and Glasgow Coma Scale score ≤ 8) within 24 h of ICU admission. To date, no prospective trial has rigorously evaluated this common therapy for benefit. BackgroundĪdministration of adrenergic blockade after severe TBI is common. To evaluate the safety, feasibility, and efficacy of combined adrenergic blockade with propranolol and clonidine in patients with severe traumatic brain injury (TBI).
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