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临床试验/NCT02086877
NCT02086877Unknown不适用

COGnitive Outcomes and WELLness in Survivors of Critical Illness

University of Toronto5 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
5
主要终点
Change in cognitive performance from day 7 after ICU discharge as measured by the Repeatable Battery for the Assessment of Neuropsychological Status [RBANS] and Trail Making Tests A and B

研究概览

简要总结

As survival rates from critical illness improve, strategies to return patients to their baseline cognitive and functional status are important research priorities. Up to 100% of ICU survivors will suffer some degree of cognitive impairment at hospital discharge and approximately 50% will have decrements that persist for years. While the mechanisms for this newly acquired brain injury are poorly understood, several risk factors have been identified. Unfortunately, it is unclear how to accurately predict long-term cognitive impairment.

Immediate opportunities to improve cognitive outcomes through risk reduction exist. The investigators propose to comprehensively study the prevalence of sleep abnormalities and their association with cognitive impairment, as it may yield potential targets for effective therapy. Moreover, the investigators will examine for gene x environment associations [APOE ε4] that may allow for genetic risk stratification of individuals at greatest risk of cognitive impairment. The investigators hypothesize that EEG [a sensitive longitudinal marker of brain dysfunction] is a novel and independent predictor of long-term cognitive impairment, and possibly a candidate intermediate end point for future clinical trials.

This study has the potential to identify novel biomarkers and risk factors for post-critical illness cognitive impairment, and may lay the foundation for rational interventions to mitigate risk in high-risk individuals.

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

  • ≥16 years of age
  • Admission to study ICU for invasive mechanical ventilation [minimum of 72 hours]

排除标准

  • Advanced cognitive impairment or unable to follow simple commands before their acute illness [e.g. end-stage Alzheimer's disease]
  • Primary neurological injury [e.g. anoxic brain injury, stroke or traumatic brain injury]
  • Anticipated death within 3 months of discharge [e.g. palliative]
  • Uncontrolled psychiatric illness at hospital admission
  • Not fluent in English
  • Unlikely to adhere with follow-up [e.g. no fixed address]
  • Residence greater than 300 kms from referral centre

结局指标

主要结局

Change in cognitive performance from day 7 after ICU discharge as measured by the Repeatable Battery for the Assessment of Neuropsychological Status [RBANS] and Trail Making Tests A and B

时间窗: 7 days, 6-months and 12-months after ICU discharge

次要结局

  • Pittsburgh Sleep Quality Index(7 days, 6- and 12-months after ICU discharge)
  • Medical Outcomes Study Short Form -36 Questionnaire (SF-36)(7 days, 6- and 12-months after ICU discharge)
  • Beck Depression Inventory-II (BDI-II)(7 days, 6- and 12-months after ICU discharge)
  • Richard Campbell Sleep Questionnaire(7 days, 6- and 12-months after ICU discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

M. Elizabeth Wilcox

Dr. M. Elizabeth Wilcox

University of Toronto

研究点 (5)

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