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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542538
• Other study ID #: U1111-1257-2830
• Status: Completed
• Start date: April 11, 2018
• Est. completion date: January 11, 2021

Study information

• Verified date: April 2021
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9905
• Est. completion date: January 11, 2021
• Est. primary completion date: June 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS, Human
• Corona Virus Infection
• Coronavirus Infections
• Respiratory Distress Syndrome, Adult
• Sepsis

Intervention

Other:
• No intervention, observational study

Locations

Country	Name	City	State
Sweden	Björn Ahlström	Falun

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Center for Clinical Research Dalarna, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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