Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 4
- 主要终点
- Diagnosis of Post-Intensive Care Syndrome (PICS)
研究概览
简要总结
Post-Intensive Care Syndrome (PICS) refers to long-term cognitive, physical, and psychological impairments that can arise after intensive care treatment. These symptoms may begin within 24 hours of ICU admission and persist for years. Affected patients and their families (PICS-F) face significant burdens, with up to 94% of relatives impacted. Given its high prevalence and socioeconomic impact, this prospective registry study aims to identify risk factors and long-term consequences of PICS and PICS-F.
The study consists of six modules, starting with data collection during ICU stays and continuing with follow-ups at various intervals post-discharge (up to five years). The primary goal is to investigate diagnostic and therapeutic strategies, while secondary objectives include identifying risk factors, determining impairment severity, and exploring biological mechanisms. Standardized questionnaires and biological samples (blood) are used for data collection.
详细描述
BACKGROUND Post-Intensive Care Syndrome (PICS) refers to newly occurring or intensified cognitive, physical, and psychological long-term effects, as well as pain and socioeconomic effects resulting from intensive care treatment. Symptoms can appear as early as 24 hours after admission to the intensive care unit (ICU) and persist for 5-15 years after discharge. The rate of affected individuals is very high. Three months after discharge due to an illness requiring intensive care, 64% of survivors were impaired in at least one of the three functional areas, and 56% were impaired after 12 months. The hospitalization of a close relative in the ICU affects the entire family system, i.e., all people with whom the patients have a significant relationship. The effects on the family or relatives are referred to as Post-Intensive Care Syndrome-Family (PICS-F), which represents a significant burden for up to 94% of relatives. PICS and PICS-F are therefore of high socioeconomic importance.
RELEVANCE Given the significant impact of PICS on patients, their families, and the socioeconomic system, gaining insights into the prevalence of risk factors and PICS criteria during ICU stay, as well as PICS and PICS-F after ICU discharge and hospital release, is highly valuable.
DESIGN
The study is divided into the following six modules:
- ICU module
- Post-ICU module 2: a) 1-3 months + 6 months, b) 1, 2, 5 years
- Environment module
- Psychiatry module
- Translational module
- Family system module (PICS-F) The participating centers take part in at least the first module, the ICU module, in which the risk factors and PICS as well as PICS-F domains are recorded during the intensive care stay. Depending on local conditions, capacity, and resources, the participating centers optionally participate in modules 2 to 6. In the individual modules, there is also the option of participating in a mode available to all centers or specialized for individual centers (e.g., functional tests that can only be performed in a PICS outpatient clinic (PICA)). For centers without PICA, follow-up observation is carried out, for example, via questionnaires. The corresponding mode of participation with and without PICA is displayed accordingly in the individual modules.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an ICU stay longer than 72 hours will be included
排除标准
- •Age < 18 years old
- •Patients who receive end-of-life care at the time of screening
结局指标
主要结局
Diagnosis of Post-Intensive Care Syndrome (PICS)
时间窗: up to 5 years
Frequency of PICS diagnosis defined as the presence of at least one new or worsened impairment in one of the PICS domains (number/percentage)
次要结局
- Frequency of PICS sub-domains(up to 5 years)
- Frailty status(up to 5 years)
- Post-Intensive Care Syndrome symptoms assessed by the PICS Questionnaire (PICSq)(up to 5 years)
- Physical function assessed by the Barthel Index(up to 5 years)
- Physical function assessed by the Timed Up-and-Go Test(up to 5 years)
- Physical function assessed by Handgrip Strength(up to 5 years)
- Physical function assessed by the 6-Minute Walk Test (6MWT)(up to 5 years)
- Physical function assessed by the 2-Minute Walk Test (2MWT)(up to 5 years)
- Physical function assessed by the SPPB(up to 5 years)
- Nutritional status assessed by the MNA(up to 5 years)
- Health-related quality of life assessed by EQ-5D-5L(up to 5 years)
- Disability assessed by the WHO Disability Assessment Schedule (WHODAS 2.0)(up to 5 years)
- Cognitive function assessed by the MiniCog(up to 5 years)
- Cognitive function assessed by the Animal Naming Test(up to 5 years)
- Cognitive function assessed by the RBANS(up to 5 years)
- Cognitive function assessed by the TMT(up to 5 years)
- Depression assessed by the PHQ(up to 5 years)
- Anxiety assessed by the GAD(up to 5 years)
- PTSD symptoms assessed by the IES-R(up to 5 years)
- Pain assessed by the McGill Pain Questionnaire(up to 5 years)
- Frequency of dysphagia(up to 5 years)
- Work ability and disability days(5 years)
- Psychiatric or psychotherapeutic care utilization(5 years)
- Noise annoyance assessed by the 11-point numeric noise-annoyance scale(5 years)
- Noise annoyance assessed by the 5-point verbal scale(5 years)
- Noise sensitivity assessed by the LEF-K questionnaire(5 years)
- ICU environmental exposure measured by HIAwear/Sensorbox(5 years)
- Atmospheric environmental exposure (ozone, nitrogen oxides, carbon monoxide, particulate matter)(5 years)
- Anxiety and depression in relatives assessed by the HADS(5 years)
- Post-traumatic stress in relatives assessed by the IES-R(5 years)
- Work ability of relatives(5 years)
- Psychiatric or psychotherapeutic care utilization by relatives(5 years)
- Body resistance (R)(up to 5 years)
- Body reactance (Xc)(up to 5 years)
研究者
Stefan Schaller
Professor of Anaesthesia and Anaesthesiological Intensive Care Medicine
Medical University of Vienna