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临床试验/NCT03470844
NCT03470844已完成不适用

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

Chelsea and Westminster NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Neurocognitive function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients under
  • 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.

结局指标

主要结局

Neurocognitive function

时间窗: 5 years

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

次要结局

  • Neuroinflammatory changes analysis.(5 years)

研究者

发起方
Chelsea and Westminster NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcela P. Vizcaychipi

Planned Care Surgery & Clinical Support Divisional Research Lead

Chelsea and Westminster NHS Foundation Trust

研究点 (1)

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