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CompletedNCT05063747Updated May 24, 2022

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

An observational study in Covid19, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-24.

Sponsored by Uppsala University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
13,537
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Covid19

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Keywords

  • Long term outcome
  • Mortality
  • COVID-19
  • Risk factors
  • Critical care
03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 13,537 is above the median of 260 across 3,188 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population consists of all patients a fulfilling the eligibility criteria.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Missing a Swedish personal identification number
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
13,537 participants (actual)
Patient registry
No

Groups and cohorts

  • COVID-19 ICU cohort

    All patients admitted to a Swedish ICU with COVID-19 with at least one year of follow up. COVID-19 is defined by the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) diagnosis U07.1 in the nationwide Swedish intensive care registry.

    Other: No intervention.

  • COVID-19 hospital admission control cohort

    Four random control patients per ICU patient matched on age legal gender and region. Controls selected from all patients admitted to a Swedish hospital with COVID-19 with at least one year of follow up not including patients in the COVID-19 ICU cohort. COVID-19 is defined by the ICD-10 diagnosis U07.1 in the nationwide Swedish national patient registry.

    Other: No intervention.

  • General population control cohort

    Four general population controls per ICU patient, matched on age, legal gender and region drawn from the total population register of Sweden. ICU and hospital admitted COVID-19 patients are not included.

    Other: No intervention.

Interventions

  • OtherNo intervention.

    Observational study. No intervention.

06

What researchers measure

Primary outcomes

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

    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

    Time frame: One year

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

    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.

    Time frame: One year

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?

    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.

    Time frame: One year

07

Study locations

1 site
  • Uppsala University
    Uppsala, 79182, Sweden
08

References and documents

Individual participant data

Plan to share: No — IPD sharing is not allowed under the ethical review approval.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2021 to primary completion in Nov 2021, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2021
First posted
Oct 1, 2021
StartActual
Oct 15, 2021
Primary completionActual
Nov 15, 2021
CompletionActual
Nov 15, 2021
Last update
May 24, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05063747
Lead sponsor
Uppsala University
Collaborators
Dalarna County Council, Sweden
Responsible party
Sponsor
First posted
Oct 1, 2021
Start date
Oct 15, 2021
Primary completion
Nov 15, 2021
Completion
Nov 15, 2021
Last update
May 24, 2022

Study contacts

Miklos Lipcsey, Professor
principal investigator · Uppsala University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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