Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT) (INDICT)
Traumatic Brain Injury
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
(1) clinical indication for emergency craniotomy with dural opening to treat acute TBI within 72 hr post-trauma
Exclusion Criteria:
- persistent bilateral non-reactive pupils or other evidence of non-survivable injury,
- decompressive craniectomy to treat refractory ICP subsequent to diffuse injury, (3) co-enrollment in another therapeutic TBI trial, and
(4) pregnancy
Sites / Locations
- University of CincinnatiRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
SD-Guided Care
Standard ICU Care
In this arm, ECoG data will be reviewed for SDs in real-time using the bedside clinical CNS monitor. As a secondary measure, recognition of SDs will be facilitated by custom software on a laptop that receives data from the CNS monitor. Data on SD occurrence will be used to guide treatment in a tier-based therapeutic escalation and de-escalation protocol with the goal of SD suppression. Therapies to be used among the tiers include adjusted targets for MAP, CPP, PaCO2, plasma glucose, temperature, as well as ketamine pharmacotherapy. Changes between tiers are determined by the success or failure of SD suppression at the given treatment level.
Management in the Standard ICU Care arm will follow published national guidelines consisting of common ICU-based targets for physiologic intervention that are thought to mitigate the development of secondary brain injuries. Continuous ECoG monitoring will be performed for seizure monitoring, but information on the course of SDs in these patients will not be used to guide care. To enforce blinding to SD-related ECoG data, the ECoG bedside software will be locked with password protection to prevent displays with frequency filtering and time/amplitude scales that are necessary to identify SDs.