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Clinical Trials/NCT04601090
NCT04601090
Completed
Not Applicable

Survival Rates and Long-term Outcomes for Patients With COVID-19 Admitted to Norwegian ICUs

Oslo University Hospital1 site in 1 country860 target enrollmentSeptember 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Oslo University Hospital
Enrollment
860
Locations
1
Primary Endpoint
ICU Survival rate
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 16, 2020
End Date
July 10, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Kristin Hofsø

PhD

Oslo University Hospital

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.

Outcomes

Primary Outcomes

ICU Survival rate

Time Frame: up to 30 days

Time to survival

Change in Functional Status

Time Frame: 6 and 12 months after ICU admission

Measured by self-reporting using Lawton Instrumental activity of daily living. Higher score indicates better function, and ranges from 0-8.

Secondary Outcomes

  • Change in Anxiety and Depression(Measured 6 and 12 months after ICU admission)
  • Change in Quality of Life 6 and 12 months after ICU admission(Measured 6 and 12 months after ICU admission)
  • Changes in Cognitive Status(Measured at 6 and 12 months after ICU admission)

Study Sites (1)

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