Jeanette Tas1, Erta Beqiri2,3, C R van Kaam4, Ari Ercole5, Gert Bellen6, D Bruyninckx6, Manuel Cabeleira2, Marek Czosnyka2, Bart Depreitere6, Joseph Donnelly2, Marta Fedriga2,7, Peter J Hutchinson8, D Menon5, Geert Meyfroidt9, Annalisa Liberti10, J G Outtrim5, C Robba11, C W E Hoedemaekers4, Peter Smielewski2, Marcel J Aries10. 1. Department of Intensive Care Medicine, University of Maastricht, Maastricht University Medical Centre, Maastricht, The Netherlands. Jeanette.tas@mumc.nl. 2. Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK. 3. Department of Physiology and Transplantation, University of Milan, Milan, Italy. 4. Department of Intensive Care Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands. 5. University Division of Anaesthesia, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK. 6. Department of Neurosciences, Catholic University Leuven, University Hospital Leuven, Leuven, Belgium. 7. Department of Anaesthesia, Critical Care and Emergency, Spedali Civili University Hospital, Brescia, Italy. 8. Department of Clinical Neurosciences, Cambridge University, Cambridge, UK. 9. Department of Cellular and Molecular Medicine, Catholic University Leuven, University Hospital, Leuven, Belgium. 10. Department of Intensive Care Medicine, University of Maastricht, Maastricht University Medical Centre, Maastricht, The Netherlands. 11. Department of Anaesthesia and Intensive Care, Policlinico San Martino, IRCCS for Oncology and Neuroscience, Genoa, Italy.
Abstract
INTRODUCTION: Monitoring of cerebral autoregulation (CA) in patients with a traumatic brain injury (TBI) can provide an individual 'optimal' cerebral perfusion pressure (CPP) target (CPPopt) at which CA is best preserved. This potentially offers an individualized precision medicine approach. Retrospective data suggest that deviation of CPP from CPPopt is associated with poor outcomes. We are prospectively assessing the feasibility and safety of this approach in the COGiTATE [CPPopt Guided Therapy: Assessment of Target Effectiveness] study. Its primary objective is to demonstrate the feasibility of individualizing CPP at CPPopt in TBI patients. The secondary objectives are to investigate the safety and physiological effects of this strategy. METHODS: The COGiTATE study has included patients in four European hospitals in Cambridge, Leuven, Nijmegen, and Maastricht (coordinating centre). Patients with severe TBI requiring intracranial pressure (ICP)-directed therapy are allocated into one of two groups. In the intervention group, CPPopt is calculated using a published (modified) algorithm. In the control group, the CPP target recommended in the Brain Trauma Foundation guidelines (CPP 60-70 mmHg) is used. RESULTS: Patient recruitment started in February 2018 and will continue until 60 patients have been studied. Fifty-one patients (85% of the intended total) have been recruited in October 2019. The first results are expected early 2021. CONCLUSION: This prospective evaluation of the feasibility, safety and physiological implications of autoregulation-guided CPP management is providing evidence that will be useful in the design of a future phase III study in severe TBI patients.
INTRODUCTION: Monitoring of cerebral autoregulation (CA) in patients with a traumatic brain injury (TBI) can provide an individual 'optimal' cerebral perfusion pressure (CPP) target (CPPopt) at which CA is best preserved. This potentially offers an individualized precision medicine approach. Retrospective data suggest that deviation of CPP from CPPopt is associated with poor outcomes. We are prospectively assessing the feasibility and safety of this approach in the COGiTATE [CPPopt Guided Therapy: Assessment of Target Effectiveness] study. Its primary objective is to demonstrate the feasibility of individualizing CPP at CPPopt in TBI patients. The secondary objectives are to investigate the safety and physiological effects of this strategy. METHODS: The COGiTATE study has included patients in four European hospitals in Cambridge, Leuven, Nijmegen, and Maastricht (coordinating centre). Patients with severe TBI requiring intracranial pressure (ICP)-directed therapy are allocated into one of two groups. In the intervention group, CPPopt is calculated using a published (modified) algorithm. In the control group, the CPP target recommended in the Brain Trauma Foundation guidelines (CPP 60-70 mmHg) is used. RESULTS:Patient recruitment started in February 2018 and will continue until 60 patients have been studied. Fifty-one patients (85% of the intended total) have been recruited in October 2019. The first results are expected early 2021. CONCLUSION: This prospective evaluation of the feasibility, safety and physiological implications of autoregulation-guided CPP management is providing evidence that will be useful in the design of a future phase III study in severe TBI patients.
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