Major InjuryPRiMeNCT03470844
Perioperative Research Into Memory: Cognitive Outcome Following Major Burns
An observational study of Major Injury, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Injury
- What is being tested?
- Face-to-face neurocognitive tests, Psychological screening and fMRI
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Aug 2015to 30 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with severe burn injury admitted to a Burn Intensive Care Unit
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Burn Intensive Care Unit (BICU), Chelsea and Westminster Hospital
London, SW10 9NH
About this study
Official title: Using Cognitive Tests and Functional MRI to Investigate Long Term Cognitive Dysfunction Following a Critical Illness Due to a Major Burn Injury
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.
Read the 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
- Being tested
- Face-to-face neurocognitive tests, Psychological screening, fMRI, Quality of Life Self-Assessment data
- Keywords
- Major burns, Intensive Care Medicine, Neurocognitive dysfunction, Functional magnetic resonance imaging, Neuroinflammation, Long term quality of life
- Medical subject headings
- Cognition Disorders, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face neurocognitive testsBehavioural
Also called - Hopkins Verbal Learning and Verbal Fluency tests, - CogState computerised battery
Assessment of attention, processing speed, working memory and executive function
Psychological screeningBehavioural
Also called - Patient health questionnaire (PHQ9), - Generalised anxiety (GAD7) scoring systems, - Trauma screening questionnaire
Screening for the symptoms of depression, anxiety and post-traumatic stress disorder
fMRIOther
Also called The functional MRI (fMRI) protocol includes:, - Resting state fMRI, - T1w-mpr, T2w-FLAIR, - Diffusion Tensor Imaging (DTI)
Brain volume, chemical markers, functional outcome
Quality of Life Self-Assessment dataBehavioural
Also called - EQ-5D
EQ-5D will be converted into a utility score using standard EQ-5D UK tariffs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Face-to-face neurocognitive tests; Behavioral: Psychological screening; Other: fMRI; Behavioral: Quality of Life Self-Assessment data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive function
Specifically to investigate cognitive tasks using a battery of computerised tests.
Measured: 5 years
Secondary outcomes (1)
Neuroinflammatory changes analysis.
Functional MRI scan
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start5 Aug 2015
- Primary completion30 Apr 2016
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, University of Westminster
- Responsible party
- Principal investigator, Marcela P. Vizcaychipi, Chelsea and Westminster NHS Foundation Trust
- Investigators
- Marcela Vizcaychipi, MD PhD FRCA, Study chair, Chelsea and Westminster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470844
- Sponsor's protocol ID
- C&W13/099
- Acronym
- PRiMe
- Status last verified
- Mar 2018
- First submitted
- 10 May 2016
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Cognitive Tests and Functional MRI to Investigate Long Term Cognitive Dysfunction Following a Critical Illness Due to a Major Burn Injury
- ClinicalTrials.gov ID
- NCT03470844
- Acronym / sponsor ID
- PRiMe / C&W13/099
- Conditions
- Major Injury
- Keywords
- Major burns, Intensive Care Medicine, Neurocognitive dysfunction, Functional magnetic resonance imaging, Neuroinflammation, Long term quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, University of Westminster
- Study start
- 5 Aug 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5-10 years post severe burn injury | – | Behavioral: Face-to-face neurocognitive tests, Behavioral: Psychological screening, Other: fMRI, Behavioral: Quality of Life Self-Assessment dataInterventions: * 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. |
| 2-5 years post severe burn injury | – | Behavioral: Face-to-face neurocognitive tests, Behavioral: Psychological screening, Other: fMRI, Behavioral: Quality of Life Self-Assessment dataInterventions: * 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. |
| 1-2 years post severe burn injury | – | Behavioral: Face-to-face neurocognitive tests, Behavioral: Psychological screening, Other: fMRI, Behavioral: Quality of Life Self-Assessment dataInterventions: * 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. |
| Control | – | Behavioral: Face-to-face neurocognitive tests, Behavioral: Psychological screening, Other: fMRI, Behavioral: Quality of Life Self-Assessment dataHealthy 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe burn injury admitted to a Burn Intensive Care Unit
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-face neurocognitive testsAlso: - Hopkins Verbal Learning and Verbal Fluency tests, - CogState computerised batteryAssessment of attention, processing speed, working memory and executive function | Behavioural | 1-2 years post severe burn injury, 2-5 years post severe burn injury, 5-10 years post severe burn injury, Control |
| Psychological screeningAlso: - Patient health questionnaire (PHQ9), - Generalised anxiety (GAD7) scoring systems, - Trauma screening questionnaireScreening for the symptoms of depression, anxiety and post-traumatic stress disorder | Behavioural | 1-2 years post severe burn injury, 2-5 years post severe burn injury, 5-10 years post severe burn injury, Control |
| fMRIAlso: The functional MRI (fMRI) protocol includes:, - Resting state fMRI, - T1w-mpr, T2w-FLAIR, - Diffusion Tensor Imaging (DTI)Brain volume, chemical markers, functional outcome | Other | 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 dataAlso: - EQ-5DEQ-5D will be converted into a utility score using standard EQ-5D UK tariffs | Behavioural | 1-2 years post severe burn injury, 2-5 years post severe burn injury, 5-10 years post severe burn injury, Control |
Primary outcome
Neurocognitive function
Time frame: 5 years
Specifically to investigate cognitive tasks using a battery of computerised tests.
1 secondary outcome
Neuroinflammatory changes analysis.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcela Vizcaychipi, MD PhD FRCA study chair
Chelsea and Westminster Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Injury, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive function (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.