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Completed

NCT Number: NCT04542538

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.

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Key information

Conditions

Sepsis ARDS, Human Corona Virus Infection Coronaviridae Infections Coronavirus Infections Infections Inflammation Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Systemic Inflammatory Response Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Björn Ahlström

Falun, 79182, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no intervention, observational study

Other

Primary outcomes

  1. Risk factors of ICU care COVID-19/Sepsis

    Time frame: 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.

  2. Risk factors of ICU care COVID-19/ARDS

    Time frame: 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.

  3. Risk factors of ICU mortality COVID-19/Sepsis

    Time frame: 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.

  4. Risk factors of ICU mortality COVID-19/ARDS

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Center for Clinical Research Dalarna, Sweden

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Sep 9, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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