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临床试验/NCT07373561
NCT07373561尚未招募不适用

Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors: An Inception Cohort Study (PICAS-DK)

Zealand University Hospital0 个研究点目标入组 800 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
800
主要终点
Presence of PICS at 12 months after ICU admission

研究概览

简要总结

The study aims to estimate the prevalence of post-intensive care syndrome (PICS) 12 months after ICU admission among adult ICU survivors in Denmark and to describe how this prevalence is distributed across the physical, cognitive, and mental health domains. By conducting follow-up assessments at 3, 6, and 12 months post-discharge, the study further seeks to determine the prevalence of PICS at each time point, characterise its temporal trajectory, and explore patients' symptom burden over time.

Research question

  • What is the prevalence of PICS and its specific components (physical, cognitive, and mental health domains) among ICU survivors 12 months after ICU admission?
  • How do the components of PICS evolve during the follow-up period (trajectory)?
  • What risk factors are associated with the development of PICS in ICU survivors?
  • Are there differences in PICS prevalence based on demographic or clinical characteristics (e.g., age, comorbidities, ICU length of stay)?

The hypothesis is that the prevalence of post-intensive care syndrome (PICS) in a Danish cohort of adult ICU survivors at 12 months will be approximately one third, defined as impairment in at least one of the three PICS domains (physical, cognitive, or mental health), measured using validated instruments with pre-specified cut-offs.

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

入选标准

  • Adult patients ≥ 18 years of age
  • Admitted to the intensive care unit for ≥48 hours
  • Acutely admitted to the intensive care unit

排除标准

  • Patients with limited treatment
  • Foreign patients
  • Pregnant women
  • Patient with impaired cognitive function (e.g. dementia, intellectual disability)
  • Patient without Danish citizenship
  • Patient with limited proficiency in the Danish language

研究组 & 干预措施

ICU patients

This study investigates ICU survivor patients in Denmark and aim to estimate the prevalence of post-intensive care syndrome within this group. There are three different follow-up times.

结局指标

主要结局

Presence of PICS at 12 months after ICU admission

时间窗: 12 months after ICU admission

Presence of PICS at 12 months after ICU admission, defined as impairment in at least one of the three domains (physical, cognitive or mental health) measured with validated instruments and pre-specified cut-off values.

次要结局

  • Prevalence of PICS at 3 and 6 months(Data will be collected at 3 and 6 months post-discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Camilla Bekker Mortensen

Assistant Professor, Ph.D, Critical Care Registered Nurse

Zealand University Hospital

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