COVID-19 in the Swedish ICU-cohort: Risk Factors of Critical Care Admission and Intensive Care Mortality

NCT04390074 — Completed, 9905 participants, Uppsala University

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RegistryNCT04390074
StatusCompleted
Study typeObservational
Enrollment9905 (Actual)
SponsorUppsala University (Other); collaborators: Center for Clinical Research Dalarna, Sweden
ConditionsCOVID-19, Critical Illness
InterventionsCOVID-19 and Intensive Care (Other)
Datesstart 2020-05-27, primary completion 2020-06-04, completion 2020-06-04, first posted 2020-05-15, last updated 2020-08-25
Locations1 site in Sweden

Related Papers Related Patents Related Grants Related Experts
All trials for COVID-19 All trials for Critical Illness All trials of COVID-19 and Intensive Care

-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, the observed associations between different comorbidities and chronic medications have not fully been related to the frequencies of the same comorbidities and chronic medications in age- and sex-matched controls from the general population. This is important since some of the proposed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of the disease.

By combining several registries, we will compare, on several comorbidities such as hypertension and diabetes and several medications such as immunosuppressant drugs and Angiotensin Converting Enzyme (ACE)-inhibitors, the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a set 8000 age- and sex-matched controls.

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+Detailed description

The 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, the observed associations between different comorbidities and chronic medications have not fully been related to the frequencies of the same comorbidities and chronic medications in age- and sex-matched controls from the general population. This is important since some of the proposed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of the disease.

By combining several registries, we will compare, on several comorbidities such as hypertension and diabetes and several medications such as immunosuppressant drugs and ACE-inhibitors, the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a set 8000 age- and sex-matched controls.

Data sources:

Registries of the Swedish board of Health and wellfare:

1. The patient registry containing information including diagnostic codes from all specialized Healthcare contacts in Sweden. Reporting i governed by law.
2. The Swedish Prescribed Drug Register to which all dispensations from pharmacies of prescribed drugs are reported.

Statistics Sweden is the agency responsible for the official population statistics of Sweden. They will draw our controls from the Registry of the total population.

The Swedish Intensive Care Registry (SIR) contains all intensive care episodes in Sweden. They have information on Intensive Care (ICU) admission, diagnoses, interventions and outcomes.

The study design is combined prospective ond retrospective. The data is prospectively collected to the registries but the study protocol is retrospectively designed.

+Arms and interventions

ArmTypeInterventionsDescription
COVID-19Other: COVID-19 and Intensive CarePatients with COVID-19 who have received or are receiving Intensive Care in Sweden. Patients are identified in the Swedish Intensive care registry, to which all Swedish intensive care units (ICU) are reporting all intensive care patients.
ControlAge- and sex-matched controls are drawn from all residents of Sweden by Statistics Sweden.
  • COVID-19 and Intensive Care (Other): No intervention, observational.

+Outcome measures

Primary outcomes

  • Chronic medications as risk factor of intensive care for COVID-19 [Drug dispensation within 6 months prior inclusion]: Odds ratio of intensive care treated patients with COVID-19 having ongoing treatment with drugs blocking the Renin-Angiotensin-Aldosterone-System (RAAS), statins, immunosuppressant drugs, oral anticoagulant drugs, oral thrombocyte aggregation inhibitors or antiviral drugs.
  • Comorbidities as risk factor of intensive care for COVID-19 [5 years prior to inclusion]: Odds ratio of intensive care treated patients with COVID-19 having been diagnosed with diabetes typ I, diabetes type II, ischemic heart disease, other heart disease, cerebrovascular disease, cancer, chronic renal failure, chronic obstructive pulmonary disease (COPD) asthma, obesity, immunosuppressed disease or systemic inflammatory disease.

Secondary outcomes

  • Chronic medications as risk factor of death during intensive care for COVID-19 [Drug dispensation within 6 months prior inclusion]: Odds ratio of patients who have died during intensive care with COVID-19 having ongoing treatment with drugs blocking the Renin-Angiotensin-Aldosterone-System (RAAS), statins, immunosuppressant drugs, oral anticoagulant drugs, oral thrombocyte aggregation inhibitors or antiviral drugs.
  • Comorbidities as risk factor of death during intensive care for COVID-19 [5 years prior to inclusion]: Odds ratio of patients who have died during intensive care with COVID-19 having been diagnosed with diabetes typ I, diabetes type II, ischemic heart disease, other heart disease, cerebrovascular disease, cancer, chronic renal failure, chronic obstructive pulmonary disease (COPD) asthma, obesity, immunosuppressed disease or systemic inflammatory disease.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

-Included in the SIR with COVID-19 any time until data acquisition

Exclusion Criteria:

-Age below 18 years.

+Locations (1)

FacilityCityCountryStatus
Björn AhlströmFalunSweden

+Investigators