Clinical trial NCT04542538: The Impact of Premorbid Illnesses on the Risk of ICU Admission and Short-term Outcome
Official title: The Impact of Premorbid Illnesses on the Risk of ICU Admission and Short-term Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Corona Virus Infection
ARDS, Human
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Center for Clinical Research Dalarna, Sweden
First posted: 2020-09-09
Enrollment: 9905
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Risk factors of ICU care COVID-19/Sepsis
timeFrame: Five years preceding ICU admission to ICU admission
measure: Risk factors of ICU care COVID-19/ARDS
timeFrame: Five years preceding ICU admission to ICU admission
measure: Risk factors of ICU mortality COVID-19/Sepsis
timeFrame: Five years preceding ICU admission to ICU discharge
measure: Risk factors of ICU mortality COVID-19/ARDS
timeFrame: Five years preceding ICU admission to ICU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Björn Ahlström
Study officials:
affiliation: Uppsala University
name: Miklos Lipcsey, PhD
role: PRINCIPAL_INVESTIGATOR
References: