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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05063747
• Other study ID #: U1111-1269-5925
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13537
• 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

• COVID-19
• Covid19

Intervention

Other:
• No intervention.
Observational study. No intervention.

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	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	One year
Primary	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.	One year
Secondary	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.	One year