Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients (FORECAST) Multi-Center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 11
- 主要终点
- Frailty status
研究概览
简要总结
A prospective observational study of critically ill patients over the age of 50, studying the occurrence of frailty as measured by a variety of frailty measures, processes of care and long term outcomes.
详细描述
Frailty is common in critically ill elderly patients, and is associated with adverse impacts on outcomes and is becoming increasingly common in Intensive Care Unit (ICU) populations. However it is not clear as to how to best measure frailty and when to do so. It is also not clear as to how processes of care impact on the outcomes observed. We 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.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must Meet both 1 and 2
- •Age > 50 years. We have selected >50 years in keeping with prior descriptions of critically ill patients [17].
- •Receipt of at least one of the following life support interventions for over 24 hours:
- •Mechanical ventilation: Both invasive and non-invasive either solely or in combination are acceptable. High flow oxygen (e.g. OPTIFLOW) as a form of Non-Invasive Ventilation (NIV) is acceptable but the patient's Fraction of Inspired Oxygen (FIO2) at the time of enrollment must be greater > 50%.
- •Vasoactive medications (vasopressors or inotropes).
- •Acute renal replacement therapy (RRT). Patient must have been admitted to ICU for the receipt of renal replacement therapy, either intermittent or continuous and after 24 hours of ICU admission, there is a continued need for further RRT.
排除标准
- •ICU admission greater than 5 days at the time of enrollment.
- •Expected to survive for less than 72 hours after study enrollment.
- •No family or caregivers available to collect collateral history.
- •Family or caregivers not able to speak English or French.
- •Projected inability to complete 6 month follow-up either by telephone or in-person.
结局指标
主要结局
Frailty status
时间窗: 6 Months
Frailty as measured with the Frailty Index (FI). The FI is indicated by the proportion of deficits present over the number measured and is scored as a fraction between 0 and 1.0. Frailty is considered to be present when the FI is \> 0.20 and the severity of frailty is considered higher with increasing values for the FI.
次要结局
- Correlation of ICU processes of care (nutritional adequacy, adverse events, mobilization and sedation) with frailty progression as measured by the Clinical Frailty Scale or Frailty Index(28 days)
- Impact of admission critical illness on the development and severity of frailty as measured by a Frailty Index or Clinical Frailty Scale(28 days and 6 months)
- Correlation of frailty severity at hospital discharge with long term outcomes (mortality, Quality of Life and Need for Institutionalization)(6 months)
- Number of patients with a measure of frailty prior to hospital discharge.(28 days)
研究者
Dr. John Muscedere
Professor of Medicine
Queen's University