drugset / Trial / NCT01322048
DASH After TBI Study: Decreasing Adrenergic or Sympathetic Hyperactivity After Traumatic Brain Injury
Phase 2
Completed
48 enrolled
Vanderbilt University
Eastern Association for the Surgery of Trauma (EAST) · collabVanderbilt University Medical Center · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The investigators intend to determine the effect of adrenergic blockade on 1) short-term physiology, behavior, and cognition and 2) long-term neuropsychological outcomes after severe Traumatic Brain Injury (TBI). The primary hypothesis is that adrenergic blockade after severe TBI will be associated with increased ventilator-free days.
Timeline
- Start
- 2011-08
- Primary completion
- 2015-01
- Completion
- 2016-12
Outcome
Missed primary endpoint
paper There was no significant difference in VFDs between treatment and control groups [0.3 days, 95% CI (- 5.4, 5.8), p = 1.0]. PMID 37296432 ↗
paper Despite the safety and feasibility of adrenergic blockade with propranolol and clonidine after severe TBI, the intervention did not alter the VFD outcome. PMID 37296432 ↗
Publications
- Nordness MF, Maiga AW, Wilson LD, Koyama T, Rivera EL, Rakhit S, de Riesthal M, Motuzas CL, Cook MR, Gupta DK, Jackson JC, Williams Roberson S, Meurer WJ, Lewis RJ, Manley GT, Pandharipande PP, Patel MB. Effect of propranolol and clonidine after severe traumatic brain injury: a pilot randomized clinical trial. Crit Care. 2023 Jun 9;27(1):228. doi: 10.1186/s13054-023-04479-6.
- Patel MB, McKenna JW, Alvarez JM, Sugiura A, Jenkins JM, Guillamondegui OD, Pandharipande PP. Decreasing adrenergic or sympathetic hyperactivity after severe traumatic brain injury using propranolol and clonidine (DASH After TBI Study): study protocol for a randomized controlled trial. Trials. 2012 Sep 26;13:177. doi: 10.1186/1745-6215-13-177.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clonidine | Other / unclassified | 0.1 mg | Other |
| Subject | Propranolol | Small molecule | 1 mg | Intravenous |