Skip to main content
OpenTrials
Completed

NCT Number: NCT04601090

Survival Rates and Longterm Outcomes After COVID-19

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 Acute Respiratory Distress Syndrome Acute Respiratory Failure COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Post Intensive Care Unit Syndrome RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Survivorship Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0027, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICU treatment

Other

This is an observational study, so all patients will undergo a variation of ICU treatment, and we will record that information (e.g., time on ventilator, time in ICU, SAPS score at admission)

Primary outcomes

  1. ICU Survival rate

    Time frame: up to 30 days

    Time to survival

  2. 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

  1. Change in Anxiety and Depression

    Time frame: 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).

  2. Changes in Cognitive Status

    Time frame: 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.

  3. Change in Quality of Life 6 and 12 months after ICU admission

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 23, 2020
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.