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

Completed

• Conditions: Sepsis; ARDS, Human; Corona Virus Infection
• Interventions: Other: No intervention, observational study

• Registration Number: NCT04542538
• Lead Sponsor: Uppsala University

Brief Summary

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.

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 Timeline

• Study Start: 2018-04-11
• Primary Completion: 2020-06-04
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-09
• Study Completion: 2021-01-11
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9905

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sepsis critical care patients	No intervention, observational study	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.
ARDS critical care patients	No intervention, observational study	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.
COVID-19 critical care patients	No intervention, observational study	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.

Primary Outcome Measures

Name	Time	Method
Risk factors of ICU mortality COVID-19/ARDS	Five years preceding ICU admission to ICU discharge	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.
Risk factors of ICU care COVID-19/Sepsis	Five years preceding ICU admission to ICU admission	In a binary logistics model with the outcome Sepsis or COVID-19 the OR for several comorbidities are determined.
Risk factors of ICU mortality COVID-19/Sepsis	Five years preceding ICU admission to ICU discharge	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.
Risk factors of ICU care COVID-19/ARDS	Five years preceding ICU admission to ICU admission	In a binary logistics model with the outcome ARDS or COVID-19 the OR for several comorbidities are determined.

Trial Locations

Locations (1)

Björn Ahlström; 🇸🇪 Falun, Sweden