Survival Rates and Longterm Outcomes After COVID-19

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Acute Respiratory Distress Syndrome; Acute Respiratory Failure; Survivorship; Post Intensive Care Unit Syndrome
• Intervention / Treatment: Other: ICU treatment

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 Type: Observational
• Enrollment (Actual): 860

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0027
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU Survival rate	Time to survival	up to 30 days
Change in Functional Status	Measured by self-reporting using Lawton Instrumental activity of daily living. Higher score indicates better function, and ranges from 0-8.	6 and 12 months after ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety and Depression	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).	Measured 6 and 12 months after ICU admission
Changes in Cognitive Status	Measured by telephone interview using the Mini Montreal Cognitive Assessment, score ranges from 0-15. Higher score indicates better cognitive function.	Measured at 6 and 12 months after ICU admission
Change in Quality of Life 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).	Measured 6 and 12 months after ICU admission

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: The Research Council of Norway
• Investigators: Principal Investigator: Kristin Hofsø, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 16, 2020
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): July 10, 2022

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (ACTUAL): October 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: ICU treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Syndrome; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 135310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No