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临床试验/NCT04605029
NCT04605029已完成不适用

Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients - A Pilot Study

Dr. John Muscedere1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年8月1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
50
试验地点
1
主要终点
Correlation of frailty severity at hospital discharge with long term outcomes (mortality, Quality of Life and Need for Institutionalization)

研究概览

简要总结

This pilot study will study the impact of critical illness and ICU processes of care on the trajectory and development of frailty. It is hypothesize that frailty in survivors of critical illness will be measurable at hospital discharge, will correlate with processes of care while in ICU and will better discriminate long term outcomes when compared to severity of illness or the degree of frailty present on ICU admission.

This pilot study will be conducted in a tertiary medical surgical ICU at Kingston General Hospital- Kingston, Ontario. It will inform the feasibility, timelines and sample size for the multi-center study and will allow for the refinement of study procedures and data collection methods. This study will be published separately as a stand-alone pilot.

详细描述

Single Center Observational pilot study to inform on the conduct of a multi-center observational study.

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
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 55 years
  • Admission to ICU for over 24 hours
  • Receipt of at least one therapeutic life support intervention that can only be delivered in the ICU such as mechanical ventilation (both invasive and non-invasive), vasoactive medications (vasopressors or inotropes) or acute renal replacement therapy.

排除标准

  • Lack of consent for study inclusion or lack of consent to be contacted for long term follow-up.
  • Expected to survive for less than 72 hours after ICU admission.
  • Inability to obtain baseline blood work less than 48 hours after ICU admission (i.e. study enrollment must occur within 48 hours of ICU admission allowing for the blood work to be done in the time allowed).
  • No family or caregivers available to collect collateral history.
  • Not able to speak English with lack of available medical translators.
  • Admission to ICU with acute structural neurological disease:
  • Massive stroke requiring ICU care
  • Spinal cord injury with neurological deficit

结局指标

主要结局

Correlation of frailty severity at hospital discharge with long term outcomes (mortality, Quality of Life and Need for Institutionalization)

时间窗: 6 months

Clinical outcomes at 6 months will include mortality, Quality of Life (EQ5L) and need for Institutionalization

Correlation of ICU processes of care (nutritional adequacy, mobilization and sedation) with frailty progression as measured by the Clinical Frailty Scale or Frailty Index

时间窗: 28 days

Correlation of processes of care in ICU (nutritional adequacy, mobilization and sedation) with frailty progression

Number of patients with a measure of frailty prior to hospital discharge.

时间窗: 6 months

Measure of the Frailty Index and Clinical Frailty Scale prior to discharge

Impact of admission critical illness on the development and severity of frailty as measured by a Frailty Index or Clinical Frailty Scale

时间窗: 28 days and at 6 months

Correlation with the progression or presence of frailty as measured with the Frailty Index or Clinical Frailty Scale

次要结局

未报告次要终点

研究者

发起方
Dr. John Muscedere
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. John Muscedere

Critical Care Research Director

Queen's University

研究点 (1)

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