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

Completed

• Conditions: Covid19
• Interventions: Other: No intervention.

• Registration Number: NCT05063747
• Lead Sponsor: Uppsala University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-01
• Study Start: 2021-10-15
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13537

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 hospital admission control cohort	No intervention.	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.
COVID-19 ICU cohort	No intervention.	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.
General population control cohort	No intervention.	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.

Primary Outcome Measures

Name	Time	Method
Is cohort an independent risk factor in a logistic model of one year mortality?	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.
What factors have significant odds ratios in a logistic model of the risk of one year mortality?	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

Secondary Outcome Measures

Name	Time	Method
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?	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.

Trial Locations

Locations (1)

Uppsala University; 🇸🇪 Uppsala, Sweden