Characteristics and Outcomes of Patients Admitted to Swedish Intensive Care Units for COVID-19

COVID-19 Clinical Trial

Official title:

Characteristics and Outcomes of Patients Admitted to Swedish Intensive Care Units for COVID-19 During the First 60 Days of the 2020 Pandemic

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04462393
• Other study ID #: SweCOVID
• Status: Active, not recruiting
• Start date: March 6, 2020
• Est. completion date: December 31, 2022

Study information

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

Clinical Trial Summary

This is a registry-based cohort study of all adult patients (≥18 years) admitted to Swedish Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the first 2 months of the 2020 pandemic.

The main goal is to describe demographic characteristics, coexisting conditions, treatments and outcomes among critically ill patients with COVID-19. A secondary goal is to identify independent risk factors associated with increased mortality for these patients.

Data regarding baseline characteristics including comorbidities, intensive care treatments and outcomes will be extracted. ICU lengths of stay and 30-day mortalities will be calculated. The primary outcome is 30-day all-cause mortality. THIS PART OF THE STUDY HAS BEEN COMPLETED.

UPDATE 26 Feb 2022:

Characteristics and outcomes of 'first wave' patients admitted to Swedish ICUs was published in Eur J Anaesthesiol. 2021 Apr 1;38(4):335-343. doi: 10.1097/EJA.0000000000001459.

A description of the surge response and aggregated data outcomes in Scandinavian countries was published in https://onlinelibrary.wiley.com/doi/10.1111/aas.13983.

ADDITIONAL SUMMARY - EXTENDED INCLUSION PERIOD AND ADDITION OF LONG-TERM OUTCOMES Due to the continued influx of patients requiring intensive care throughout 2020 and 2021, we extended the inclusion period to 30 June 2021. Thus this new cohort will include all patients admitted to ICUs in Sweden from 6 March 2020 to 30 June 2021.

We will investigate short (30day mortality) and long-term outcomes (365d mortality and cardiovascular complications) of patients admitted to Swedish ICUs with confirmed SARS-CoV-2 infection and COVID-19 disease.

Description:

Previous studies reporting outcomes for COVID-19 patients admitted to intensive care units (ICUs) have been hampered by right-censoring after short observation periods. None have reported 30-day mortality rates and the vast majority of studies have substantial proportions of undischarged patients at the time of follow-up. The lack of follow-up at least to ICU discharge may cause bias in reported mortality rates. Further, national data on critically ill patients have not been previously published.

UPDATE 26 Feb 2022: A number of large, cohort studies including national population outcomes have now been published.

This is a registry-based cohort study of all adult patients (≥18 years) admitted to Swedish Intensive Care Units with confirmed SARS-CoV-2 infection and COVID-19 disease during the first 2 months of the 2020 pandemic. The Swedish Intensive Care Registry (SIR) collects data on patients admitted to all Swedish ICUs, with 100% coverage since 2019. Thus, SIR is able to report on outcomes in a national intensive care population without selection. Little is known about the epidemiology of COVID-19 infections in Sweden, which has one of the world's highest life expectancies and a significant burden of comorbidity. Coupled with Sweden's 'relaxed' approach to COVID-19 pandemic management, health care outcomes are understandably under question.

The main goal is to describe demographic characteristics, coexisting conditions, treatments and outcomes among critically ill patients with COVID-19. A secondary goal is to identify independent risk factors associated with increased mortality for these patients.

ADDITIONAL SUMMARY updated 20 October 2021 Due to the continued influx of COVID-19 patients in ICUs in Sweden throughout 2020 and 2021, we extended of our sample size to encompass all patients admitted up to 30 June 2021 (previously 6 May 2020).

We aim to investigate short- and long-term outcomes including mortality and the incidence of new cardiovascular and respiratory diagnoses up to one year after inclusion.

On 22 mar 2021 we received ethical committee approval for these extensions.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7500
• Est. completion date: December 31, 2022
• Est. primary completion date: May 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (=18 years)

• COVID-19 disease

Exclusion Criteria:

• No Swedish personal identity number

• 'Opt out' from Swedish Intensive Care Registry

Related Conditions & MeSH terms

• COVID-19
• Critical Illness

Intervention

Other:
• Admission to ICU for COVID-19
All patients admitted to Swedish ICUs with COVID-19 between 6 Mar - 6 May 2020

Locations

Country	Name	City	State
Sweden	Department of Anaesthesia and Intensive Care, Linkoeping University Hospital, Region Östergötland	Linköping	Östergötland

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	Region Östergötland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	all-cause	30 days
Primary	365-day mortality	all-cause	365 days (additional outcome added Oct 2021 after additional approval from ethical committee)
Secondary	ICU mortality	all cause	30 days
Secondary	Morbidity	Cardiovascular and Respiratory Diseases	up to 365 days after study inclusion