Major Injury Clinical Trial
Official title:
Using Cognitive Tests and Functional MRI to Investigate Long Term Cognitive Dysfunction Following a Critical Illness Due to a Major Burn Injury
The long term survival of patients who require admission to critical care (CC) following a
major burn injury (MBI) continues to improve with advanced clinical management. There has
been increasing interest into cognitive dysfunction (CD) due to neuroinflammation (NI)
following CC, anaesthesia, surgery, and the association of NI with diseases characterised by
CD such as Alzheimer's disease. Patients who suffer a MBI and who subsequently require
admission to CC will be at uniquely high risk for CD. MBI produces an exaggerated and
prolonged systemic inflammatory response, with NI demonstrated in animal models. Additionally
NI can be exaggerated by insults such as sepsis, anaesthesia, and surgical trauma, common and
often necessary following MBI. The aim of this study is to identify CD using cognitive tests
to examine for deficits in working memory and executive function. Test proposed to use are
the Hopkins Verbal Learning and Verbal Fluency tests, and a validated computerised battery
(CogState). Neuroinflammation and underlying pathophysiology using fMRI and spectroscopy,
known to demonstrate biomarkers for CD and NI. QoL will be assessed using the validated EQ-5D
tool.
The Inclusion criteria; patients who survive their burns injury (greater than 15% total body
surface area) and require mechanical ventilation. Primary exclusion criteria; admission with
toxic epidermal necrolysis syndrome, and evidence of head trauma.
This is a novel, proof of principle, prospective, cohort design, observational clinical study to assess for functional brain reorganisation, structural changes and long-term cognitive dysfunction following major burns injury and intensive care admission. The hypothesis is that following a major burns injury and intensive care admission patients will have neurocognitive dysfunction and demonstrable functional alterations seen on functional MRI due to neuroinflammation as a result of the primary injury and subsequent inflammatory insults. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00844896 -
Intervention to Reduce Stress in 0-5 Year Olds With Burns
|
N/A |