PRIME: Cognitive Outcome Following Major Burns

NCT03242395 | Completed DMC

• 1 other identifier: 14/LO/0049
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

PRIME aims to demonstrate through neurocognitive assessment that BICU patients will have a degree of neurocognitive dysfunction following a major burn, that this neurocognitive dysfunction is due to an underlying neuroinflammatory process by fMRI neuroimaging techniques, and that the neurocognitive deficit is associated with a reduced quality of life.

Conditions

Cognitive Dysfunction; Burns; Inflammation, Brain; Quality of Life; Anxiety; Depression; PostTraumatic Stress Disorder

Keywords

Neuroinflammation; fMRI; Post-operative cognitive dysfunction; Systemic inflammation; Severe burns

Outcome Measures

Primary Outcomes (1)

• Neurocognitive deficit

  Median T score of cognitive results (verbal ability, verbal and visual learning, short-term memory, working memory, executive function, attention and processing speed)

  Within 10 years of injury

Secondary Outcomes (2)

• Quality of Life

  Within 10 years of injury

• Neuroinflammation

  Within 10 years of injury

Study Arms (2)

Burn patients

Adult survivors of severe burns who have been admitted to Burns ITU for invasive ventilation within 10 years of neurocognitive assessment

Controls

Healthy volunteers, controlled for age/sex/IQ

Eligibility Criteria

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

Study Population

Severe burns survivors

You may qualify if:

• Invasive ventilation on a Burns Intensive Care Unit (BICU) within the previous ten years
• Burn injuries greater than 15% total body surface area (TBSA)
• Adult

You may not qualify if:

• Admission to BICU for other illnesses that were not burn related (such as Toxic Epidermal Necrolysis Syndrome)
• Evidence of head trauma
• Known substance misuse or alcohol excess
• Inability to understand plain verbal or written English
• Severe mental health issues
• Receiving formal psychiatric treatment
• Currently held under the Mental Health Act
• Imprisoned
• Contraindications to MRI
• non-compatible pacemakers
• surgical metalwork or foreign bodies
• severe claustrophobia

Sponsors & Collaborators

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

Study Sites (1)

Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 9NH, United Kingdom

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Burns; Encephalitis; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcela P Vizcaychipi, MD PhD

  Anaesthetic and Intensive Care Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: August 8, 2017
• Study Start: October 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 8, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)