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

NCT04542538 | Completed

• 1 other identifier: U1111-1257-2830
• Study Type: observational
• Target: 9,905
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Corona Virus Infection; ARDS, Human

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

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

Interventions

No intervention, observational study OTHER

ARDS critical care patients; COVID-19 critical care patients; Sepsis critical care patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ° Individual registered in the Swedish intensive care registry (SIR) with COVID-19 Before 27 May 2020.
• Individual registered in the SIR with Severe sepsis or septic chock 2011-2016. or
• Individual registered in the SIR with ARDS 2011-2016.

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead
• Center for Clinical Research Dalarna, Sweden: collaborator

Study Sites (1)

Björn Ahlström

Falun, 79182, Sweden

Location

MeSH Terms

Conditions

Sepsis; Coronavirus Infections; Respiratory Distress Syndrome

Interventions

Observation

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Miklos Lipcsey, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: September 9, 2020
• Study Start: April 11, 2018
• Primary Completion: June 4, 2020
• Study Completion: January 11, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)