Skip to main content
OpenTrials
Completed

NCT Number: NCT05075096

Long Term Outcome in ICU Treated COVID-19: New Chronic Diseases

Additional chronic diseases one year after intensive care unit (ICU) admission with Coronavirus disease 2019 (COVID-19) will be assessed in comparison to two control cohorts.

The ICU population comprises all Swedish ICU patients with COVID-19 with at least one year of follow up. The hospital admitted cohort comprises four hospital admitted patients with COVID-19 per ICU patient, matched on age, legal gender and region. The general population controls are matched to the ICU patients in a one to four fashion on age, legal gender and region.

ICU patients are identified in the Swedish intensive care registry. The hospital admitted patients are identified in the national patient registry and the population controls are identified in the population registry. Data on comorbidity, medications and death are provided from the National board of health and welfare.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University

Uppsala, 79182, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Admitted to a Swedish ICU and registered in the Swedish intensive care registry with the ICD 10 diagnosis U07.1 before 1 July 2020. ICU-cohort.

or randomly selected from all patients admitted to hospital but not ICU with the ICD 10 diagnosis U07.1 in the national patient registry, matched on age, legal gender and region (four per ICU patient) before 1 July 2020. Hospital cohort.

or randomly selected from the general population (and not included in the ICU or hospital admitted cohorts), matched on age, legal gender and region (four per ICU patient)

Exclusion criteria

  • Missing a Swedish personal identification number

Treatment and study plan

No intervention.

Other

No intervention observational study.

Primary outcomes

  1. Is the illness severity in COVID-19 (according to level of care cohort) an independent risk factor for incident chronic renal failure within one year after inclusion?

    Time frame: One year

    Variables in binary logistic model with the outcome incident chronic renal failure: On sick leave one year before ICU admission, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status co-morbid diabetes mellitus. Interaction with a variable denoting cohort (ICU, Hospital or General population) is added to all variables. A significant interaction indicates a differential effect between cohorts.

  2. Is the illness severity in COVID-19 (according to level of care cohort) an independent risk factor for incident pulmonary disease within one year after inclusion?

    Time frame: One year

    Variables in binary logistic model with the outcome incident pulmonary disease: On sick leave one year before ICU admission, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status. Interaction with a variable denoting cohort (ICU, Hospital or General population) is added to all variables. A significant interaction indicates a differential effect between cohorts.

  3. Is the illness severity in COVID-19 (according to level of care cohort) an independent risk factor for incident cardiac failure within one year after inclusion?

    Time frame: One year

    Variables in binary logistic model with the outcome incident cardiac failure: On sick leave one year before ICU admission, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status co-morbid ischemic heart disease. Interaction with a variable denoting cohort (ICU, Hospital or General population) is added to all variables. A significant interaction indicates a differential effect between cohorts.

  4. Is the illness severity in COVID-19 (according to level of care cohort) an independent risk factor for incident pulmonary hypertension within one year after inclusion?

    Time frame: One year

    Variables in binary logistic model with the outcome incident pulmonary hypertension: On sick leave one year before ICU admission, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status co-morbid chronic obstructive pulmonary disease. Interaction with a variable denoting cohort (ICU, Hospital or General population) is added to all variables. A significant interaction indicates a differential effect between cohorts.

  5. Is the illness severity in COVID-19 (according to level of care cohort) an independent risk factor for being diagnosed with Post COVID (ICD-10, U09.9) within one year after inclusion?

    Time frame: One year

    Variables in binary logistic model with the outcome Post COVID: On sick leave one year before ICU admission, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status. Interaction with a variable denoting cohort (ICU, Hospital or General population) is added to all variables. A significant interaction indicates a differential effect between cohorts.

  6. Is the illness severity in COVID-19 (according to level of care cohort) an independent risk factor for incident psychiatric disease within one year after inclusion?

    Time frame: One year

    Variables in binary logistic model with the outcome incident psychiatric disease: On sick leave one year before ICU admission, age, legal gender, highest education, immigrant background, income the year before inclusion, marital status. Interaction with a variable denoting cohort (ICU, Hospital or General population) is added to all variables. A significant interaction indicates a differential effect between cohorts.

Secondary outcomes

  1. Is the prevalence of pulmonary disease, chronic renal failure, pulmonary hypertension, cardiac failure or psychiatric diseases more common one year after than before ICU admission with COVID-19?

    Time frame: One year

    Analyzed in the ICU admitted cohort.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Dalarna County Council, Sweden

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 12, 2021
Registry last updated
May 24, 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.