4-Year Mortality, Functional Outcomes, and Quality of Life After ICU-Treated COVID-19-Related ARDS: A Retrospective-Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 283
- 试验地点
- 1
- 主要终点
- All-Cause Mortality at 30 Days
研究概览
简要总结
This observational cohort study describes long-term survival and patient-reported health after intensive care unit (ICU) treatment for COVID-19-related acute respiratory distress syndrome (ARDS) in adults treated in a single center in Poland. The main questions it aims to answer are:
- What is all-cause mortality up to 4 years after ICU admission for COVID-19-related ARDS?
- Among long-term survivors, what are the health-related quality of life and functional outcomes approximately 4 years after ICU admission?
- What rehabilitation use, return-to-work outcomes, and self-reported financial burden are reported during follow-up, and which acute-phase clinical and laboratory factors are associated with late mortality and long-term outcomes?
Participants did not receive any experimental intervention as part of this study. The study team collected clinical information from hospital and ICU records and conducted a structured telephone follow-up with survivors using standardized questionnaires (including EQ-5D-5L for quality of life, the modified Medical Research Council [mMRC] scale for breathlessness, and the Post-COVID-19 Functional Status [PCFS] scale for functional status), as well as questions about rehabilitation and work status.
详细描述
This is an observational retrospective-prospective cohort study of adults treated in the intensive care unit (ICU) for COVID-19-related acute respiratory distress syndrome (ARDS) at a single center in Poland (University Hospital in Zielona Góra / Temporary COVID-19 Hospital in Zielona Góra). The cohort includes consecutive eligible ICU admissions between December 2020 and July 2021. No experimental intervention was assigned as part of this study.
Acute-phase clinical data were obtained from routinely collected hospital and ICU documentation. These data include baseline demographics, pre-existing comorbidities, severity of illness, and organ dysfunction at ICU admission, selected laboratory and physiological parameters, and key aspects of ICU management and clinical course. Long-term vital status was assessed for approximately 4 years after ICU admission, using available clinical records and follow-up procedures described in the protocol.
A structured telephone follow-up was conducted approximately 4 years after ICU admission among long-term survivors to collect patient-reported outcomes using standardized instruments and a predefined interview script. The follow-up assessment captured health-related quality of life, breathlessness, and functional status, and also included questions on post-discharge rehabilitation, return-to-work status, and self-reported financial burden related to recovery.
Analyses are descriptive and exploratory. Mortality over time is described using time-to-event methods, and associations between selected acute-phase variables and late mortality and long-term patient-reported outcomes are evaluated using multivariable models, with appropriate handling of missing data and sensitivity analyses as specified in the statistical analysis plan. The study was conducted with approval from the relevant ethics committee, and participant consent procedures for the follow-up interview were implemented in accordance with local requirements.
Time perspective: Retrospective extraction of acute-phase ICU data (December 2020-July 2021) with a single structured telephone follow-up of survivors approximately 4 years after ICU admission.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Baseline cohort (retrospective ICU cohort)
- •Adults (≥18 years) admitted to the Temporary Hospital in Zielona Góra ICU between December 2020 and July 2021
- •Confirmed SARS-CoV-2 infection
- •COVID-19-related acute respiratory distress syndrome (ARDS)
- •Required invasive mechanical ventilation during ICU treatment
- •Prospective follow-up component (telephone interview):
- •Confirmed alive at approximately 4 years after ICU admission
- •Agreed to participate in a structured telephone interview (voluntary participation)
排除标准
- •Baseline cohort:
- •None (no additional clinical exclusion criteria)
- •Prospective follow-up component (telephone interview):
- •Declined participation in the telephone interview
- •Unable to be reached after repeated contact attempts (non-responder)
研究组 & 干预措施
ICU-Treated COVID-19 ARDS Cohort
Consecutive adult patients treated in the intensive care unit (ICU) for COVID-19-related acute respiratory distress syndrome (ARDS) at a single center in Poland, admitted between December 2020 and July 2021. This was an observational study with no assigned experimental intervention. Long-term vital status was assessed up to approximately 4 years after ICU admission; survivors were invited to a structured telephone follow-up to assess patient-reported outcomes.
结局指标
主要结局
All-Cause Mortality at 30 Days
时间窗: 30 days after ICU admission
Proportion of participants who died from any cause within 30 days of ICU admission.
All-Cause Mortality up to 4 Years
时间窗: From ICU admission up to 4 years after ICU admission
Proportion of participants who died from any cause from ICU admission through 4 years after ICU admission (cumulative mortality).
次要结局
- Late All-Cause Mortality Among 30-Day Survivors(Day 31 through 4 years after ICU admission)
- Health-Related Quality of Life (EQ-5D-5L Index Value)(Approximately 4 years after ICU admission (single telephone follow-up assessment))
- Self-Rated Health (EQ Visual Analogue Scale [EQ-VAS])(Approximately 4 years after ICU admission (single telephone follow-up assessment))
- Functional Status (Post-COVID-19 Functional Status [PCFS] Grade)(Approximately 4 years after ICU admission (single telephone follow-up assessment))
- Breathlessness Severity (modified Medical Research Council [mMRC] Score)(Approximately 4 years after ICU admission (single telephone follow-up assessment))
- Subjective Cognitive Complaints (Two Screening Items Adapted From the Cognitive Failures Questionnaire [CFQ])(Approximately 4 years after ICU admission (single telephone follow-up assessment))
- Sleep Disturbance (Single Screening Item)(Approximately 4 years after ICU admission (single telephone follow-up assessment))
- Time to Return to Work(Assessed at approximately 4 years after ICU admission (recall of post-discharge period))
- Post-Discharge Rehabilitation Exposure and Duration(Assessed at approximately 4 years after ICU admission (recall of post-discharge period))
研究者
Jacek Zawadzki
MD PhD
University in Zielona Góra