The Burn Intensive Care Unit (BICU), Chelsea and Westminster Hospital
London, SW10 9NH, United Kingdom
NCT Number: NCT03470844
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.
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Notify Me16 year and older
All sexes
Observational
London, SW10 9NH, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Assessment of attention, processing speed, working memory and executive function
Other names: - Hopkins Verbal Learning and Verbal Fluency tests, - CogState computerised battery
Screening for the symptoms of depression, anxiety and post-traumatic stress disorder
Other names: - Patient health questionnaire (PHQ9), - Generalised anxiety (GAD7) scoring systems, - Trauma screening questionnaire
Brain volume, chemical markers, functional outcome
Other names: The functional MRI (fMRI) protocol includes:, - Resting state fMRI, - T1w-mpr, T2w-FLAIR, - Diffusion Tensor Imaging (DTI), - Spectroscopy, - Double inversion recovery (DIR) and Perfusion ASL
EQ-5D will be converted into a utility score using standard EQ-5D UK tariffs
Other names: - EQ-5D
Time frame: 5 years
Specifically to investigate cognitive tasks using a battery of computerised tests.
Time frame: 5 years
Functional MRI scan
Time frame: 5 years
EQ-5D
Chelsea and Westminster NHS Foundation Trust
Other
Using Cognitive Tests and Functional MRI to Investigate Long Term Cognitive Dysfunction Following a Critical Illness Due to a Major Burn Injury
Acronym: PRiMe
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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