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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
| University of Westminster | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-10 years post severe burn injury | Interventions:
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| 2-5 years post severe burn injury | Interventions:
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| 1-2 years post severe burn injury | Interventions:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Face-to-face neurocognitive tests | Behavioral | Assessment of attention, processing speed, working memory and executive function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive function | Specifically to investigate cognitive tasks using a battery of computerised tests. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Neuroinflammatory changes analysis. | Functional MRI scan | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term quality of Life | EQ-5D | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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Patients with severe burn injury admitted to a Burn Intensive Care Unit
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| Name | Affiliation | Role |
|---|---|---|
| Marcela Vizcaychipi, MD PhD FRCA | Chelsea and Westminster Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Burn Intensive Care Unit (BICU), Chelsea and Westminster Hospital | London | SW10 9NH | United Kingdom |
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| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009422 | Nervous System Diseases |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D000073222 | Patient Health Questionnaire |
| D056324 | Diffusion Tensor Imaging |
| D013057 | Spectrum Analysis |
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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|
| Control | Healthy age, gender, socioeconomic and educational level matched control. Interventions:
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| Psychological screening | Behavioral | Screening for the symptoms of depression, anxiety and post-traumatic stress disorder |
|
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| fMRI | Other | Brain volume, chemical markers, functional outcome |
|
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| Quality of Life Self-Assessment data | Behavioral | EQ-5D will be converted into a utility score using standard EQ-5D UK tariffs |
|
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D038524 | Diffusion Magnetic Resonance Imaging |
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003943 | Diagnostic Techniques, Neurological |
| D002623 | Chemistry Techniques, Analytical |