Perioperative Research Into Memory: Cognitive Outcome Following Major Burns

NCT03470844 | Completed DMC

• 1 other identifier: C&W13/099
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Major burns; Intensive Care Medicine; Neurocognitive dysfunction; Functional magnetic resonance imaging; Neuroinflammation; Long term quality of life

Outcome Measures

Primary Outcomes (1)

• Neurocognitive function

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

  5 years

Secondary Outcomes (1)

• Neuroinflammatory changes analysis.

  5 years

Other Outcomes (1)

• Long-term quality of Life

  5 years

Study Arms (4)

5-10 years post severe burn injury

Interventions: * Face-to-face neurocognitive tests examining attention, processing speed, working memory and executive function. * Psychological screening for the symptoms of depression, anxiety and post-traumatic stress disorder using the patient health questionnaire (PHQ9), generalised anxiety (GAD7) scoring systems and the trauma screening questionnaire. * fMRI studies including resting state fMRI, T1w-mpr, T2w-FLAIR, Diffusion Tensor Imaging (DTI) with 30 directions, Spectroscopy CSI chemical shift imaging, Spectroscopy SVS single voxel, susceptibility weighted imaging (SWI), double inversion recovery (DIR) and Perfusion ASL. * Quality of Life Self-Assessment data.

Behavioral: Face-to-face neurocognitive tests; Behavioral: Psychological screening; Other: fMRI; Behavioral: Quality of Life Self-Assessment data

2-5 years post severe burn injury

Interventions: * Face-to-face neurocognitive tests examining attention, processing speed, working memory and executive function. * Psychological screening for the symptoms of depression, anxiety and post-traumatic stress disorder using the patient health questionnaire (PHQ9), generalised anxiety (GAD7) scoring systems and the trauma screening questionnaire. * fMRI studies including resting state fMRI, T1w-mpr, T2w-FLAIR, Diffusion Tensor Imaging (DTI) with 30 directions, Spectroscopy CSI chemical shift imaging, Spectroscopy SVS single voxel, susceptibility weighted imaging (SWI), double inversion recovery (DIR) and Perfusion ASL. * Quality of Life Self-Assessment data.

Behavioral: Face-to-face neurocognitive tests; Behavioral: Psychological screening; Other: fMRI; Behavioral: Quality of Life Self-Assessment data

1-2 years post severe burn injury

Interventions: * Face-to-face neurocognitive tests examining attention, processing speed, working memory and executive function. * Psychological screening for the symptoms of depression, anxiety and post-traumatic stress disorder using the patient health questionnaire (PHQ9), generalised anxiety (GAD7) scoring systems and the trauma screening questionnaire. * fMRI studies including resting state fMRI, T1w-mpr, T2w-FLAIR, Diffusion Tensor Imaging (DTI) with 30 directions, Spectroscopy CSI chemical shift imaging, Spectroscopy SVS single voxel, susceptibility weighted imaging (SWI), double inversion recovery (DIR) and Perfusion ASL. * Quality of Life Self-Assessment data.

Behavioral: Face-to-face neurocognitive tests; Behavioral: Psychological screening; Other: fMRI; Behavioral: Quality of Life Self-Assessment data

Control

Healthy age, gender, socioeconomic and educational level matched control. Interventions: * Face-to-face neurocognitive tests examining attention, processing speed, working memory and executive function. * Psychological screening for the symptoms of depression, anxiety and post-traumatic stress disorder using the patient health questionnaire (PHQ9), generalised anxiety (GAD7) scoring systems and the trauma screening questionnaire. * fMRI studies including resting state fMRI, T1w-mpr, T2w-FLAIR, Diffusion Tensor Imaging (DTI) with 30 directions, Spectroscopy CSI chemical shift imaging, Spectroscopy SVS single voxel, susceptibility weighted imaging (SWI), double inversion recovery (DIR) and Perfusion ASL. * Quality of Life Self-Assessment data.

Behavioral: Face-to-face neurocognitive tests; Behavioral: Psychological screening; Other: fMRI; Behavioral: Quality of Life Self-Assessment data

Interventions

Face-to-face neurocognitive tests BEHAVIORAL

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

Also known as: - Hopkins Verbal Learning and Verbal Fluency tests, - CogState computerised battery

1-2 years post severe burn injury; 2-5 years post severe burn injury; 5-10 years post severe burn injury; Control

Psychological screening BEHAVIORAL

Screening for the symptoms of depression, anxiety and post-traumatic stress disorder

Also known as: - Patient health questionnaire (PHQ9), - Generalised anxiety (GAD7) scoring systems, - Trauma screening questionnaire

1-2 years post severe burn injury; 2-5 years post severe burn injury; 5-10 years post severe burn injury; Control

fMRI OTHER

Brain volume, chemical markers, functional outcome

Also known as: 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

1-2 years post severe burn injury; 2-5 years post severe burn injury; 5-10 years post severe burn injury; Control

Quality of Life Self-Assessment data BEHAVIORAL

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

Also known as: - EQ-5D

1-2 years post severe burn injury; 2-5 years post severe burn injury; 5-10 years post severe burn injury; Control

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe burn injury admitted to a Burn Intensive Care Unit

You may qualify if:

• 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

You may not qualify if:

• Patients under 16.
• Patients with toxic epidermal necrolysis syndrome or evidence of head trauma.
• Patient refusal or inability to give full informed consent.
• Patients unable to understand plain verbal or written English.

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead
• Imperial College Healthcare NHS Trust: collaborator
• University of Westminster: collaborator

Study Sites (1)

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

London, SW10 9NH, United Kingdom

Location

MeSH Terms

Conditions

Cognition Disorders; Neuroinflammatory Diseases

Interventions

Patient Health Questionnaire; Diffusion Tensor Imaging; Spectrum Analysis

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Chemistry Techniques, Analytical

Study Officials

• Marcela Vizcaychipi, MD PhD FRCA

  Chelsea and Westminster Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Planned Care Surgery & Clinical Support Divisional Research Lead

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: March 20, 2018
• Study Start: August 5, 2015
• Primary Completion: April 30, 2016
• Study Completion: October 30, 2017
• Last Updated: March 20, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)