Official Title
4-Year Mortality, Functional Outcomes, and Quality of Life After ICU-Treated COVID-19-Related ARDS: A Retrospective-Prospective Cohort Study
Brief Summary

This observational cohort study describes long-term survival and patient-reported healthafter intensive care unit (ICU) treatment for COVID-19-related acute respiratory distresssyndrome (ARDS) in adults treated in a single center in Poland. The main questions itaims to answer are: 1. What is all-cause mortality up to 4 years after ICU admission for COVID-19-related ARDS? 2. Among long-term survivors, what are the health-related quality of life and functional outcomes approximately 4 years after ICU admission? 3. 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. Thestudy team collected clinical information from hospital and ICU records and conducted astructured 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 forfunctional status), as well as questions about rehabilitation and work status.

Detailed Description

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.

Completed
COVID-19
ARDS (Acute Respiratory Distress Syndrome)
Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Poland
Locations

University in Zielona Góra
Zielona Góra, Lubusz Voivodeship, Poland

Not Provided

University in Zielona Góra
NCT Number
Keywords
Intensive care unit
ICU survivors
long-term outcomes
4-year follow-up
Health-related quality of life
EQ-5D-5L
modified Medical Research Council (mMRC)
Post-COVID-19 Functional Status (PCFS)
Rehabilitation
return to work
financial burden
MeSH Terms
COVID-19
Acute Lung Injury
Financial Stress