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

Sponsor
Uppsala University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05075096
Collaborator
Dalarna County Council, Sweden (Other)
20,000
Enrollment
1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: No intervention.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20000 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Long Term Outcome in ICU Treated COVID-19: New Chronic Diseases
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

ArmIntervention/Treatment
COVID-19 ICU cohort

All patients admitted to a Swedish ICU with COVID-19 with at least one year of follow up. COVID-19 defined by the ICD-10 diagnosis U07.1 in the nationwide Swedish intensive care registry.

Other: No intervention.
No intervention observational study.

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 defined by the ICD-10 diagnosis U07.1 in the nationwide Swedish national patient registry.

Other: No intervention.
No intervention observational study.

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. Not including ICU and hospital admitted COVID-19 patients.

Other: No intervention.
No intervention observational study.

Outcome Measures

Primary Outcome Measures

  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? [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? [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? [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? [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? [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? [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 Outcome Measures

  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? [One year]

    Analyzed in the ICU admitted cohort.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Uppsala University
  • Dalarna County Council, Sweden

Investigators

  • Principal Investigator: Miklos Lipcsey, Professor, 202100-2932

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Uppsala University
ClinicalTrials.gov Identifier:
NCT05075096
Other Study ID Numbers:
  • U1111-1269-6916
First Posted:
Oct 12, 2021
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Uppsala University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021