Improving Intensive Care Through Biobanking: a Strategic Approach to Understanding Post-Intensive Care Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Incidence of PICS and its components
研究概览
简要总结
The goal of this observational study is to explore the development and progression of Post-Intensive Care Syndrome (PICS) in adult ICU patients by establishing a biobank of biological samples and outcome data. This biobank-based research is designed to investigate the physical, cognitive, and psychological health outcomes of ICU survivors and their relationship with potential biomarkers. The study population includes adult ICU patients aged 18-65, who have stayed in the ICU for at least 48 hours.
The main questions it aims to answer are:
What is the incidence of PICS and its main components? What risk factors are associated with the development of PICS six months post-ICU discharge? What are the long-term effects of ICU admission on quality of life, cognitive health, and physical function?
Participants will:
Provide blood samples during ICU admission and at follow-up visits at 4-5 weeks, 6 months, and 10-12 months after discharge.
Complete assessments measuring quality of life, cognitive health, anxiety, depression, PTSD symptoms, physical function, and pulmonary function.
Participate in three follow-up visits at the ICU Recovery Clinic after discharge to monitor PICS symptoms and recovery progress.
This study does not involve an intervention but will gather data that could improve our understanding of PICS and inform strategies for post-ICU care. The data collected will be crucial for identifying PICS biomarkers and will contribute to developing targeted, personalized interventions for ICU survivors in the future.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU stay of at least 48 hours
- •Age between 18 and 65 years at the time of ICU admission
- •Written informed consent
排除标准
- •Transfer from another ICU outside of the Medical University of Vienna
- •Patient with a legal guardian
- •Homelessness
- •Place of residence outside of Austria
结局指标
主要结局
Incidence of PICS and its components
时间窗: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Incidence of Post-Intensive Care Syndrome (PICS), defined as new or worsened impairments in physical, cognitive, or mental function persisting beyond hospital stay. Patients scoring above/below predefined cut-offs on any of the assessments (detailed below) will be diagnosed with PICS.
Health-related quality of life (HRQoL) using EQ-5D-5L
时间窗: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
a. The EQ-5D-5L is a responsive, reliable, and robust way of measuring health across a wide range of conditions and populations. It has been translated and validated in 200 languages and includes five dimensions of health: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. The questionnaire will be scored overall and within each category.
Health-Related Quality of Life (HRQoL) using SF-36
时间窗: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
HRQoL assessed with SF-36, covering eight health domains. Results will be aggregated into two composite scores: Physical Component Summary (PCS) and Mental Component Summary (MCS), with higher scores indicating a more favorable health state.
Cognitive Function using Montreal Cognitive Assessment (MoCA)
时间窗: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Cognitive function measured by the MoCA, with scores below 24 indicating impairment. Only patients with prior normal cognitive function are eligible.
Cognitive Function using Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
时间窗: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Cognitive decline assessed with IQCODE, a validated informant questionnaire. Scores range from 1 (much improved) to 5 (much worse), with a cutoff average score of ≥3.31 indicating cognitive decline.
Anxiety and Depression Symptoms using HADS
时间窗: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Anxiety and depression symptoms measured with HADS. Subscale scores ≥8 indicate significant anxiety or depression.
Post-traumatic stress disorder (PTSD) symptoms using Impact of Event Scale-Revised (IES-R)
时间窗: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
PTSD symptoms measured with the IES-R. Scores range from 0 (not at all) to 4 (extremely), with an average score of ≥1.6 indicating clinically significant PTSD symptoms.
Physical Function using 6-Minute Walk Test (6MWT)
时间窗: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Deterioration in the 6-Minute Walking Test (6-MWT) defined as a change in the target value of the walking distance calculated using the following equation: 218 + (5,14 x height - 5,32 x age) - 1,8 x weight + 51,31 x gender (height in cm, age in years, weight in kg, female 0 / male 1)
Physical Function using using Chelsea Critical Care Physical Assessment Tool (CPAx)
时间窗: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Physical function measured by CPAx, assessing various functional activities (grip strength, respiratory function, moving, sitting, standing, transferring, and stepping). Each domain is scored from 0 to 5, with an overall score from 0 (dependent) to 50 (fully independent).
Pulmonary Function - FEV1/FVC Ratio
时间窗: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Pulmonary function assessed by FEV1/FVC ratio (Tiffeneau index); a value below the 5th percentile indicates obstructive ventilation disorder.
Pulmonary Function using Total Lung Capacity (TLC)
时间窗: at 4-5 weeks, 6 months and 10-12 months after ICU discharge
Pulmonary function assessed by total lung capacity (TLC), where values below the 5th percentile indicate a restrictive ventilation disorder.
次要结局
- Pain and Discomfort using EQ-5D-5L(4-5 weeks, 6 months and 10-12 months after ICU discharge)
- Frailty Status using Clinical Frailty Scale(4-5 weeks, 6 months and 10-12 months after ICU discharge)
研究者
Akos Tiboldi
Physician
Medical University of Vienna