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Corticosteroids in Severe COVID-19 (ASAP-ESICM/ESAIC Study)

NCT ID: NCT04866082

Last Updated: 2023-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

466 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-30

Study Completion Date

2022-06-30

Brief Summary

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Brief Summary: Administration of systemic corticosteroids for patients with severe forms of severe acute respiratory syndrome in coronavirus-2 (SARS-CoV-2) infection are recommended by several guidelines. In the very beginning of SARS-CoV-2 pandemic the early recommendation by professional organization was against routine use of corticosteroids for patients with coronavirus disease 2019 (COVID-19) ARDS, despite previous data and clinical practice for patients with refractory or severe form of acute respiratory distress syndrome (ARDS). But recently after publication of RECOVERY trial (Randomized Evaluation of Covid-19 Therapy, July 2020) and ensued metaanalysis of World Health Organization (WHO) working group, routine administration of systemic corticosteroids was revisited. However, there is an ongoing debate regarding evidence supporting the dose, type of administration (bolus vs. continuous infusion), timing and type of corticosteroids. Ongoing randomized controlled trials (RCTs) are challenging the recommendation of 6 mg of dexamethasone for all patients with severe form of COVID-19. Due to the dynamics of COVID-19 surges and rapid issuing of official recommendations, daily clinical practice of systemic corticosteroids administration can vary. An electronic evaluation form containing 20 questions will be sent to European Society of Intensive Care (ESICM) and European Society of Anaesthesiology and Intensive Care (ESAIC) members. Participants will be asked to describe their routine clinical practice regarding administration of systemic corticosteroids among patients with COVID-19 ARDS.

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Detailed Description

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Brief Summary: Administration of systemic corticosteroids for patients with severe forms of SARS-CoV-2 infection are recommended by several guidelines. In the very beginning of SARS-CoV-2 pandemic the early recommendation by professional organization was against routine use of corticosteroids for patients with coronavirus disease 2019 (COVID-19) ARDS, despite previous data and clinical practice for patients with refractory or severe form of ARDS. But recently after publication of RECOVERY trial (Randomized Evaluation of Covid-19 Therapy, July 2020) and ensued metaanalysis of WHO working group, routine administration of systemic corticosteroids was revisited. However, there is an ongoing debate regarding evidence supporting the dose, type of administration (bolus vs. continuous infusion), timing and type of corticosteroids. Ongoing RCTs (Randomized Clinical Trials) are challenging the recommendation of 6 mg of dexamethasone for all patients with severe form of COVID-19. Due to the dynamics of COVID-19 surges and rapid issuing of official recommendations, daily clinical practice of systemic corticosteroids administration can vary. An electronic evaluation form containing 20 questions will be sent to European Society of Intensive Care (ESICM) European Society of Anaesthesiology and Intensive Care (ESAIC) members. Participants will be asked to describe their routine clinical practice regarding administration of systemic corticosteroids among patients with COVID-19 ARDS.

Conditions

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Severe COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ESICM and ESAIC members

questionnaire - Members of European Society of Intensive Care and European Society of Anaesthesiology and Intensive Care will obtain an electronic survey regarding their routine clinical practice of systemic corticosteroids administration among patients with COVID-19 ARDS

questionnaire

Intervention Type OTHER

Members of European Society of Intensive Care and European Society of ANaesthesiology and Intensive care will obtain an electronic survey regarding their routine clinical practice of systemic corticosteroids administration among patients with COVID-19 ARDS

Interventions

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questionnaire

Members of European Society of Intensive Care and European Society of ANaesthesiology and Intensive care will obtain an electronic survey regarding their routine clinical practice of systemic corticosteroids administration among patients with COVID-19 ARDS

Intervention Type OTHER

Other Intervention Names

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electronic survey

Eligibility Criteria

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Inclusion Criteria

* Members of European Society of Intensive Care (ESICM)
* Members of European Society of Anaesthesiology and Intensive Care (ESAIC)

Exclusion Criteria

* not members of European Society of Intensive Care (ESICM)
* not members of European Society of Anaesthesiology and Intensive Care (ESAIC)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Society of Intensive Care Medicine

OTHER

Sponsor Role collaborator

European Society of Anaesthesiology and Intensive Care

OTHER

Sponsor Role collaborator

Brno University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jan Malaska

assoc.prof.MD,Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Malaska, assoc. prof. MD., Ph.D.

Role: STUDY_DIRECTOR

University Hospital Brno

Petr Stourac, prof.MD.Ph.D.

Role: STUDY_CHAIR

Faculty of medicince Masaryk University and University Hospital Brno

Locations

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Brno University Hospital

Brno, South Moravian, Czechia

Site Status

Countries

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Czechia

Other Identifiers

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ASAP-ESICM/ESAIC

Identifier Type: -

Identifier Source: org_study_id

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