NCT03470844

Perioperative Research Into Memory: Cognitive Outcome Following Major Burns

Using Cognitive Tests and Functional MRI to Investigate Long Term Cognitive Dysfunction Following a Critical Illness Due to a Major Burn Injury

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Chelsea and Westminster NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Major Injury

Interventions

Type	Name	Description
BEHAVIORAL	Face-to-face neurocognitive tests	Assessment of attention, processing speed, working memory and executive function
BEHAVIORAL	Psychological screening	Screening for the symptoms of depression, anxiety and post-traumatic stress disorder
OTHER	fMRI	Brain volume, chemical markers, functional outcome
BEHAVIORAL	Quality of Life Self-Assessment data	EQ-5D will be converted into a utility score using standard EQ-5D UK tariffs

Timeline

• Start date: 2015-08-05
• Primary completion: 2016-04-30
• Completion: 2017-10-30
• First posted: 2018-03-20
• Last updated: 2018-03-20

Locations

1 site across 1 country: United Kingdom