دورية أكاديمية
Targeting Autoregulation-Guided Cerebral Perfusion Pressure after Traumatic Brain Injury (COGiTATE): A Feasibility Randomized Controlled Clinical Trial.
| العنوان: | Targeting Autoregulation-Guided Cerebral Perfusion Pressure after Traumatic Brain Injury (COGiTATE): A Feasibility Randomized Controlled Clinical Trial. |
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| المؤلفون: | Tas J; Department of Intensive Care Medicine, University Maastricht (KEMTA), Maastricht University Medical Center+, Maastricht, The Netherlands.; School for Mental Health and Neuroscience (MHeNS), University Maastricht (KEMTA), Maastricht University Medical Center+, Maastricht, The Netherlands., Beqiri E; Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom., van Kaam RC; Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands., Czosnyka M; Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom.; Institute of Electronic Systems, Warsaw University of Technology, Poland., Donnelly J; Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom., Haeren RH; School for Mental Health and Neuroscience (MHeNS), University Maastricht (KEMTA), Maastricht University Medical Center+, Maastricht, The Netherlands.; Department of Neurosurgery, University Maastricht (KEMTA), Maastricht University Medical Center+, Maastricht, The Netherlands., van der Horst ICC; Department of Intensive Care Medicine, University Maastricht (KEMTA), Maastricht University Medical Center+, Maastricht, The Netherlands.; Cardiovascular Research Institute Maastricht (CARIM), University Maastricht (KEMTA), Maastricht University Medical Center+, Maastricht, The Netherlands., Hutchinson PJ; Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom., van Kuijk SMJ; Department of Clinical Epidemiology and Medical Technology Assessment, University Maastricht (KEMTA), Maastricht University Medical Center+, Maastricht, The Netherlands., Liberti AL; Department of Intensive Care Medicine, University Maastricht (KEMTA), Maastricht University Medical Center+, Maastricht, The Netherlands.; Department of Anaesthesia and Intensive Care, San Carlo Borromeo Hospital, Milan, Italy., Menon DK; Division of Anaesthesia, University of Cambridge, Cambridge, United Kingdom., Hoedemaekers CWE; Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands., Depreitere B; Neurosurgery, University Hospitals Leuven, KU Leuven, Leuven, Belgium., Smielewski P; Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, United Kingdom., Meyfroidt G; Department and Laboratory of Intensive Care Medicine, KU Leuven, Leuven, Belgium., Ercole A; Division of Anaesthesia, University of Cambridge, Cambridge, United Kingdom., Aries MJH; Department of Intensive Care Medicine, University Maastricht (KEMTA), Maastricht University Medical Center+, Maastricht, The Netherlands.; School for Mental Health and Neuroscience (MHeNS), University Maastricht (KEMTA), Maastricht University Medical Center+, Maastricht, The Netherlands. |
| المصدر: | Journal of neurotrauma [J Neurotrauma] 2021 Oct 15; Vol. 38 (20), pp. 2790-2800. Date of Electronic Publication: 2021 Aug 16. |
| نوع المنشور: | Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Mary Ann Liebert Country of Publication: United States NLM ID: 8811626 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-9042 (Electronic) Linking ISSN: 08977151 NLM ISO Abbreviation: J Neurotrauma Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Larchmont, NY : Mary Ann Liebert Original Publication: New York, NY : Mary Ann Liebert, c1988- |
| مواضيع طبية MeSH: | Homeostasis* , Perfusion*, Brain Injuries, Traumatic/*physiopathology, Adult ; Aged ; Cerebrovascular Circulation ; Endpoint Determination ; Feasibility Studies ; Female ; Humans ; Male ; Middle Aged ; Neurophysiological Monitoring ; Retrospective Studies ; Software ; Treatment Outcome |
| مستخلص: | 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. |
| معلومات مُعتمدة: | BRC-1215-20014 United Kingdom DH_ Department of Health; MR N013433-1 United Kingdom MRC_ Medical Research Council |
| فهرسة مساهمة: | Keywords: cerebral autoregulation; cerebral perfusion; intensive care; optimal cerebral perfusion pressure; precision medicine; traumatic brain injury |
| تواريخ الأحداث: | Date Created: 20210818 Date Completed: 20220217 Latest Revision: 20240229 |
| رمز التحديث: | 20240229 |
| DOI: | 10.1089/neu.2021.0197 |
| PMID: | 34407385 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1557-9042 |
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| DOI: | 10.1089/neu.2021.0197 |