Open AccessTargeting Autoregulation-Guided Cerebral Perfusion Pressure after Traumatic Brain Injury (COGiTATE): A Feasibility Randomized Controlled Clinical Trial
Author(s) -
Jeanette Tas,
Erta Beqiri,
Ruud C van Kaam,
Marek Czosnyka,
Joseph Donnelly,
Roel Haeren,
Iwan C. C. van der Horst,
Peter J. Hutchinson,
Sander M J van Kuijk,
Annalisa Liberti,
David Me,
Cornelia Hoedemaekers,
Bart Depreitere,
Peter Smielewski,
Geert Meyfroidt,
Ari Ercole,
Marcel Aries
Publication year - 2021
Publication title -
journal of neurotrauma
Language(s) - Uncategorized
Resource type - Journals
SCImago Journal Rank - 1.653
H-Index - 149
eISSN - 1557-9042
pISSN - 0897-7151
DOI - 10.1089/neu.2021.0197
Subject(s) - medicine , traumatic brain injury , randomized controlled trial , cerebral perfusion pressure , intracranial pressure , interquartile range , clinical endpoint , anesthesia , guideline , autoregulation , cerebral blood flow , surgery , blood pressure , pathology , psychiatry
Managing traumatic brain injury (TBI) patients with a cerebral perfusion pressure (CPP) near to the cerebral autoregulation (CA)-guided "optimal" CPP (CPPopt) value is associated with improved outcome and might be useful to individualize care, but has never been prospectively evaluated. This study evaluated the feasibility and safety of CA-guided CPP management in TBI patients requiring intracranial pressure monitoring and therapy (TBIicp patients). The CPPopt Guided Therapy: Assessment of Target Effectiveness (COGiTATE) parallel two-arm feasibility trial took place in four tertiary centers. TBIicp patients were randomized to either the Brain Trauma Foundation (BTF) guideline CPP target range (control group) or to the individualized CA-guided CPP targets (intervention group). CPP targets were guided by six times daily software-based alerts for up to 5 days. The primary feasibility end-point was the percentage of time with CPP concordant (±5 mm Hg) with the set CPP targets. The main secondary safety end-point was an increase in therapeutic intensity level (TIL) between the control and intervention group. Twenty-eight patients were randomized to the control and 32 patients to the intervention group. CPP in the intervention group was in the target range for 46.5% (interquartile range, 41.2-58) of the monitored time, significantly higher than the feasibility target specified in the published protocol (36%; p < 0.001). There were no significant differences between groups for TIL or for other safety end-points. Conclusively, targeting an individual and dynamic CA-guided CPP is feasible and safe in TBIicp patients. This encourages a prospective trial powered for clinical outcomes.