The Impact of Premorbid Illnesses on the Risk of ICU Admission and Short-term Outcome

The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, it is still unclear if the observed associations between different comorbidities and chronic medications and severe COVID-19 disease and mortality is different from associations between the same factors and other severe diseases requiring intensive care unit (ICU) -care. This is important since some of the observed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of any disease. By combining several registries, this study will compare, on several comorbidities such as hypertension and diabetes , the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a Swedish sepsis-cohort and a Swedish adult respiratory distress syndrome (ARDS) -cohort.

Study Overview

• Status: Completed
• Conditions: Sepsis; Corona Virus Infection; ARDS, Human
• Intervention / Treatment: Other: No intervention, observational study

Detailed Description

The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, it is still unclear if the observed associations between different comorbidities and chronic medications and severe COVID-19 disease and mortality is different from associations between the same factors and other severe diseases requiring ICU-care. This is important since some of the observed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of any disease. By combining several registries, this study will compare, on several comorbidities such as hypertension and diabetes , the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a Swedish sepsis-cohort and a Swedish ARDS-cohort.

• Study Type: Observational
• Enrollment (Actual): 9905

Contacts and Locations

Study Locations

• Sweden
  • Falun, Sweden, 79182
    • Björn Ahlström

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The SIR is a registry to which all Swedish intensive care units are reporting all intensive care patients. The SIR has a specific part to wich all COVID-19 related intensive care eposodes are reported. All patients, approximally 2000, who have at least one COVID-19 listing in the SIRI will be included, as cases. Two historical control populations are extracted from the SIR between 2011 and 2016. One population with all patients having had severe sepsis and one with all patients having had ARDS during ICU care.

We already have recieved all data on the studypopulation and the Control populations but will not set up the database or perform any analyses until this registration is be public.

Description

Inclusion Criteria:

° Individual registered in the Swedish intensive care registry (SIR) with COVID-19 Before 27 May 2020.

or

• Individual registered in the SIR with Severe sepsis or septic chock 2011-2016. or
• Individual registered in the SIR with ARDS 2011-2016.

Exclusion Criteria:

• Age below 18 years
• Individual registered in the Swedish intensive care registry without a personal identification number

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 critical care patients; All patients who have received intensive care with COVID-19 in Sweden until May 27, 2020. Patients are identified in the Swedish Intensive care registry, to which all Swedish intensive care units (ICU) are reporting all intensive care patients.	Other: No intervention, observational study
Sepsis critical care patients; All patients who have received intensive care with severe sepsis or septic shock in Sweden between 2011 and 2016. Patients are identified in the Swedish Intensive care registry, to which all Swedish intensive care units (ICU) are reporting all intensive care patients.	Other: No intervention, observational study
ARDS critical care patients; All patients who have received intensive care with ARDS in Sweden between 2011 and 2016. Patients are identified in the Swedish Intensive care registry, to which all Swedish intensive care units (ICU) are reporting all intensive care patients.	Other: No intervention, observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors of ICU care COVID-19/Sepsis	In a binary logistics model with the outcome Sepsis or COVID-19 the OR for several comorbidities are determined.	Five years preceding ICU admission to ICU admission
Risk factors of ICU care COVID-19/ARDS	In a binary logistics model with the outcome ARDS or COVID-19 the OR for several comorbidities are determined.	Five years preceding ICU admission to ICU admission
Risk factors of ICU mortality COVID-19/Sepsis	In a Cox proportional hazards model with the outcome ICU-mortality the hazard ratio (HR) for the interaction between several comorbidities and a binary variable COVID-19/Sepsis are determined.	Five years preceding ICU admission to ICU discharge
Risk factors of ICU mortality COVID-19/ARDS	In a Cox proportional hazards model with the outcome ICU-mortality the HR for the interaction between several comorbidities and a binary variable COVID-19/ARDS are determined.	Five years preceding ICU admission to ICU discharge

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Center for Clinical Research Dalarna, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2018
• Primary Completion (Actual): June 4, 2020
• Study Completion (Actual): January 11, 2021

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Coronavirus Infections; Respiratory Distress Syndrome
• Other Study ID Numbers: U1111-1257-2830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No