Survival Rates and Longterm Outcomes After COVID-19

Completed

• Conditions: Post Intensive Care Unit Syndrome; Survivorship; Covid19; Acute Respiratory Distress Syndrome; Acute Respiratory Failure

• Registration Number: NCT04601090
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2020-09-16
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-23
• Primary Completion: 2021-06-30
• Status Verified: 2022-07
• Study Completion: 2022-07-10
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 860

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICU Survival rate	up to 30 days	Time to survival
Change in Functional Status	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 Outcome Measures

Name	Time	Method
Change in Anxiety and Depression	Measured 6 and 12 months after ICU admission	Measured by self-report using Hospital Anxiety and Depression Scale (HADS). Higher score indicates higher lever of anxiety and depression, scored on separate sub scales (0-21 for each).
Change in Quality of Life 6 and 12 months after ICU admission	Measured 6 and 12 months after ICU admission	Measured by self report using (Euroqual 5 dimensions) EQ-5D. Higher score indicates worse health (range 5-15).
Changes in Cognitive Status	Measured at 6 and 12 months after ICU admission	Measured by telephone interview using the Mini Montreal Cognitive Assessment, score ranges from 0-15. Higher score indicates better cognitive function.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway