Ignite Creation Date:
2024-05-06 @ 9:26 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02982122
Status:
COMPLETED
Last Update Posted:
2020-09-30
First Post:
2016-11-23
Brief Title:
CPPopt Guided Therapy Assessment of Target Effectiveness
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
A Randomized Clinical Trial Assessing the Effect of Optimal Cerebral Perfusion Pressure Monitoring in the Management of Severe Traumatic Brain Injury
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COGITATE
Brief Summary:
Despite improvements in management mortality in severe traumatic brain injury TBI remains 25 and only 40 of patients survive without major handicap Medicalsurgical interventions aim to maintain adequate brain perfusion which is critically dependent on cerebral perfusion pressure CPP calculated as the difference between mean arterial pressure MAP and intracranial pressure ICP Current guidelines aim for a CPP above 50 mmHg based on population means However this one size fits all approach is flawed because the relation between CPP and brain perfusion varies between individuals Further this approach takes no account of autoregulation a key protective mechanism that maintains cerebral perfusion despite CPP fluctuations
Autoregulation is variably preserved following TBI and there are large between patient variances in the optimal CPP CPPopt at which autoregulation operates best Individual CPPopt can be retrieved automatically by plotting autoregulation data against the CPP over a certain time window The investigators have shown that maintenance of CPP close to CPPopt is associated with improved outcomes These data pose the hypothesis that optimisation of management in individuals may be achieved by using the zone of optimal autoregulation as a basis for defining individualised CPP targets
The investigators propose together with collaborators in the CPPopt study group Maastricht Cambridge Leuven and Aachen to set up a pilot multicenter feasibility study to develop a protocol for a definitive outcome randomized controlled trial RCT This study aims to develop protocols for CPPopt guided critical care and show that they maintain patients closer to their optimum perfusion levels than standard protocols which keep above a population CPP threshold of 60 mmHg
Hence the main objective is to offer clinicians monitoring and therapy algorithms that achieve individualized optimal CPPopt targets and potentially improve TBI outcome
Autoregulation is variably preserved following TBI and there are large between patient variances in the optimal CPP CPPopt at which autoregulation operates best Individual CPPopt can be retrieved automatically by plotting autoregulation data against the CPP over a certain time window The investigators have shown that maintenance of CPP close to CPPopt is associated with improved outcomes These data pose the hypothesis that optimisation of management in individuals may be achieved by using the zone of optimal autoregulation as a basis for defining individualised CPP targets
The investigators propose together with collaborators in the CPPopt study group Maastricht Cambridge Leuven and Aachen to set up a pilot multicenter feasibility study to develop a protocol for a definitive outcome randomized controlled trial RCT This study aims to develop protocols for CPPopt guided critical care and show that they maintain patients closer to their optimum perfusion levels than standard protocols which keep above a population CPP threshold of 60 mmHg
Hence the main objective is to offer clinicians monitoring and therapy algorithms that achieve individualized optimal CPPopt targets and potentially improve TBI outcome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None