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NCT Number: NCT05063747

Long Term Outcome in ICU Treated COVID-19: Risk Factors for 1-year Mortality

Mortality within one year after intensive care unit (ICU) admission with Coronavirus disease 2019 (COVID-19) will be assessed. Risk and risk factors for one year mortality in ICU patients will be compared to patients admitted to hospital with COVID-19 and general population controls.

The ICU population comprises all Swedish ICU patients with COVID-19 with at lease 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 socioeconomics and income are provided by the Statistics Sweden. Data on comorbidity, medications and death are provided from the National board of health and welfare.

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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

Observational study. No intervention.

Primary outcomes

  1. What factors have significant odds ratios in a logistic model of the risk of one year mortality?

    Time frame: One year

    Variables in a binary logistic model on mortality one year after ICU admission: age, legal gender, highest education, immigrant background, income previous year, martial status, ischemic heart disease, chronic renal failure, stroke, type 2 diabetes melitus, chronic obstructive pulmonary disease, asthma, hypertension, malignacy, treatment with renin angiotensin angiotensinogen inhibitors, treatment with statins

  2. Is cohort an independent risk factor in a logistic model of one year mortality?

    Time frame: One year

    Binary logistic model, interaction with a variable denoting cohort (ICU, Hospital or General population). A significant interaction denotes a differential effect of a risk factor between cohorts.

    Variables in a binary logistic model on mortality one year after ICU admission: age, legal gender, highest education, immigrant background, income previous year, martial status, ischemic heart disease, chronic renal failure, stroke, type 2 diabetes melitus, chronic obstructive pulmonary disease, asthma, hypertension, malignancy, treatment with renin-angiotensin-angiotensinogen inhibitors and treatment with statins.

Secondary outcomes

  1. Does acute disease severity, hospital length of stay or ICU length of stay affect the significance of variables when added to the risk model in Outcome 1 for the ICU cohort?

    Time frame: One year

    Addition of Simplified Acute Physiology Score 3, hospital length of stay and ICU length of stay is added to the logistic model in Outcome 1.

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 1, 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.

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