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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05075096
• Other study ID #: U1111-1269-6916
• Status: Completed
• Start date: October 15, 2021
• Est. completion date: November 15, 2021

Study information

• Verified date: May 2022
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60000
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• COVID-19
• Covid19

Intervention

Other:
• No intervention.
No intervention observational study.

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Dalarna County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?	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.	One year
Primary	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?	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.	One year
Primary	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?	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.	One year
Primary	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?	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.	One year
Primary	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?	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.	One year
Primary	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?	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.	One year
Secondary	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?	Analyzed in the ICU admitted cohort.	One year