Clinical trial NCT04601090: Survival Rates and Longterm Outcomes After COVID-19
Official title: Survival Rates and Long-term Outcomes for Patients With COVID-19 Admitted to Norwegian ICUs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Acute Respiratory Failure
Acute Respiratory Distress Syndrome
Post Intensive Care Unit Syndrome
Survivorship
Keywords: ICU treatment
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2020-10-23
Enrollment: 860
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that have been admitted to a Norwegian ICU with confirmed COVID-19, and not reserved them against the national register, will be contacted for inclusion to the study.

Brief summary: The study 'Survival rates and long-term outcomes for patients with COVID-19 admitted to Norwegian ICUs' is a national observational study, including patients admitted to a Norwegian ICU between March 2020 and March 2021. The study will describe survival rates, clinical characteristics and health challenges experienced by survivors the first year after ICU admission caused by COVID-19 disease.

Detailed description: The study 'Survival rates and long-term outcomes for patients with COVID-19 admitted to Norwegian ICUS' has two different aims. The first aim is to synthesis data from a National register (Norwegian Intensive care register-NIR) on all COVID-19 patients in Norway admitted to an ICU. These results are of great public interest for many reasons. First of all, it will give us information on the severity of this novel virus, but also how the health care system has coped in treating the severe cases that was admitted to an ICU. The results will potentially be compared to other patient populations with viral pneumonia, but most interestingly to survival rates from other countries. In addition, the data will give us a description on how the distribution of severe cases of COVID-19 have been within Norway (e.g., gender, age, health regions etc.) The second aim of this study is to measure and describe health related challenges COVID-19 patients may experience during their first year from ICU admission. The health-related domains that will be investigated will capture both mental, physical and cognitive health. Knowledge from other patient population admitted to an ICU with acute respiratory failure, indicates that these are the main domains that negatively affect the activity of daily living. Physical, mental and cognitive health challenges will be investigated for the Norwegian COVID -19 population admitted to ICU, and will give important insight to the impact COVID-19 can have on survivors of severe cases, as well as the need for rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Patients registered in Norwegian Intensive Care Register, that are ≥ 18 years with confirmed cases of COVID-19.

Exclusion Criteria:

* Exclusion criteria only for follow-up study: Do not understand Norwegian.

Primary outcomes:
measure: ICU Survival rate
timeFrame: up to 30 days
measure: Change in Functional Status
timeFrame: 6 and 12 months after ICU admission
Secondary outcomes:
measure: Change in Anxiety and Depression
timeFrame: Measured 6 and 12 months after ICU admission
measure: Changes in Cognitive Status
timeFrame: Measured at 6 and 12 months after ICU admission
measure: Change in Quality of Life 6 and 12 months after ICU admission
timeFrame: Measured 6 and 12 months after ICU admission
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kristin Hofsø, PhD
role: PRINCIPAL_INVESTIGATOR
References: