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Completed

NCT Number: NCT03470844

Perioperative Research Into Memory: Cognitive Outcome Following Major Burns

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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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Burn Intensive Care Unit (BICU), Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Survival following admission to Chelsea and Westminster Burns Intensive Care Unit between 2004-2013 with a burn injury > 15% total body surface area, requiring intubation and ventilation

Exclusion criteria

  • Patients under 16.
  • Patients with toxic epidermal necrolysis syndrome or evidence of head trauma.
  • Patients with evidence of risk to psychological safety from inclusion in study: any patient currently held under section of the Mental Health Act, any patient receiving formal psychiatric treatment (including involvement in a Personality Disorder Unit, being under voluntary section, current re-occurrence of chronic self harm), any patient currently detained at her Majesty's pleasure, any current substance abuse, or at the discretion of professional opinion following historical assessment of notes. - Patients with contraindications to MRI (patients with non-compatible pacemakers, patients with metallic foreign bodies e.g. metal sliver in their eye, patients with non-compatible surgical metal work, patients with severe claustrophobia).
  • Patient refusal or inability to give full informed consent.
  • Patients unable to understand plain verbal or written English.

Treatment and study plan

Face-to-face neurocognitive tests

Behavioral

Assessment of attention, processing speed, working memory and executive function

Other names: - Hopkins Verbal Learning and Verbal Fluency tests, - CogState computerised battery

Psychological screening

Behavioral

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

fMRI

Other

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

Quality of Life Self-Assessment data

Behavioral

EQ-5D will be converted into a utility score using standard EQ-5D UK tariffs

Other names: - EQ-5D

Primary outcomes

  1. Neurocognitive function

    Time frame: 5 years

    Specifically to investigate cognitive tasks using a battery of computerised tests.

Secondary outcomes

  1. Neuroinflammatory changes analysis.

    Time frame: 5 years

    Functional MRI scan

Other outcomes

  1. Long-term quality of Life

    Time frame: 5 years

    EQ-5D

Sponsors and collaborators

Lead sponsor

Chelsea and Westminster NHS Foundation Trust

Other

Collaborators

  • Imperial College Healthcare NHS Trust
  • University of Westminster

Registry information

Official study title

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

Acronym: PRiMe

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 20, 2018
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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