MONITOR-IC: a Mixed Methods Multicenter Prospective Open Cohort Study Determining and Improving Long-term Outcomes of ICU Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50,000
- 试验地点
- 1
- 主要终点
- Health related quality of life
研究概览
简要总结
Due to advances in critical care medicine, more patients survive their critical illness. However, intensive care unit (ICU) survivors often experience long-term physical, cognitive and mental problems, summarized as post intensive care syndrome (PICS), impacting their health related quality of life (HRQoL).
The aims of this study are to study the: 1) long-term outcomes, 2) predictors for PICS, 3) prediction of long-term HRQoL, 4) ratio between HRQoL of ICU-survivors and healthcare related costs, and 5) effects on the long-term of interventions
详细描述
Specific research questions:
- What are the post-intensive care symptoms that patients experience after their ICU admissions and what is their HRQoL?
- What are important predictors for the various physical, cognitive and mental long- term outcomes and health related quality of live outcome, using traditional statistical techniques and sophisticated AI/ML techniques?
- What is the ratio between HRQoL and healthcare related costs?
- What are experiences of patients regarding their problems and quality of life after the ICU?
- What are the effects of interventions aimed to improve long-term outcomes of ICU patients?
Design:
The MONITOR-IC study is an ongoing multicenter prospective open cohort study in which long-term outcomes of ICU patients are studied for a period of two to five years.
The study is carried out in several ICUs in the Netherlands; including academic hospitals, and non-academic hospitals. ICU patients are recruited from July 2016 onwards and followed for two to five years.
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
- 否
入选标准
- •ICU patients age 16 years or older;
- •admitted at least 12 hours to a trauma, medical, neurosurgery or cardiac surgery ICU;
- •gave written informed consent (or by their legal representative).
排除标准
- •Patients with a life expectancy of <48 hours;
- •receive palliative care;
- •are admitted for a donor procedure;
- •cannot read and speak the Dutch language;
- •or are not able to fill in the questionnaire and do not have family members/ legal representatives either.
结局指标
主要结局
Health related quality of life
时间窗: 2-5 year post-ICU
SF-12
次要结局
- Health related quality of life(2 year post-ICU)
- Frailty as part of Physical-Cognitive-Mental impairments(2 year post-ICU)
- Fatigue as part of Physical-Cognitive-Mental impairments(2 year post-ICU)
- Post traumatic stress disorder as part of Physical-Cognitive-Mental impairments(2 year post-ICU)
- Patients' care and support needs and social consequences(2 year post-ICU)
- Cognition as part of Physical-Cognitive-Mental impairments(2-5 year post-ICU)
- Anxiety and depression as part of Physical-Cognitive-Mental impairments(2 year post-ICU)
- Patients' healthcare use and related costs(2 year post-ICU)