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Perioperative Research Into Memory: Cognitive Outcome Following Major Burns

NCT03470844 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2018-03-20

No results posted yet for this study

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.

Conditions

  • Major Injury

Interventions

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

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • University of Westminster

    collaborator OTHER

  • Chelsea and Westminster NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Marcela Vizcaychipi, MD PhD FRCA · Chelsea and Westminster Hospital

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-05
Primary Completion
2016-04-30
Completion
2017-10-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03470844 on ClinicalTrials.gov