An interventional study of For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols. in Brain Injuries, Traumatic, Cerebrovascular Circulation and Homeostasis, sponsored by Maastricht University Medical Center. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-30.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
Despite improvements in management, mortality in severe traumatic brain injury (TBI) remains 25% and only 40% of patients survive without major handicap. Medical/surgical 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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 60 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients are managed according to Brain Trauma Foundation guidelines, except for CPP where the CPPopt is targeted.
Other: For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols.
Patients are managed according to Brain Trauma Foundation guidelines with CPP between 60 and 70 mmHg. CPPopt information is recorded but hidden for the treating clinicians.
Other: For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols.
For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols.
Percentage of monitoring time with measured CPP within 5 mmHg of calculated CPPopt
Main feasible endpoint: In pilot studies, we showed that, on average, patients spent a mean (+SD) of 30% ( 8%) of their monitored time with measured CPP within 5 mmHg of CPPopt. The study will be powered to target an increase in this metric to 50% of monitored time.
Time frame: First 5 days during intensive care unit admission
Treatment Intensity Level (TIL) score
Main safety secondary endpoint: A change in daily TIL score of \> 3 is representative of a clinical significant escalation of TBI treatment from basic ICP management to second tier therapies known to carry risk of harm and therefore is expected to represent a clinically significant potentially harmful effect of CPPopt guided management.
Time frame: First 5 days during intensive care unit admission
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Maastricht University Medical Center