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

February 21, 2023 updated by: Jan Malaska, Brno University Hospital

Administration of Systemic Corticosteroids Among Critically Ill Patients With COVID-19: Electronic Survey Within European Society of Intensive Care (ESICM) and European Society of Anaesthesiology and Intensive Care Members (ASAP-ESICM/ESAIC Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

466

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • South Moravian Region
      • Brno, South Moravian Region, Czechia, 62500
        • Brno University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: 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
Other Names:
  • electronic survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Administration of systemic corticosteroids among patients with COVID-19 ARDS practice in European countries - questionnaire (electronic survey)
Time Frame: 2 months
Electronic survey will be send to the European Society of intensive care (ESICM) members via email
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brno University Hospital

Collaborators

European Society of Intensive Care Medicine
European Society of Anaesthesiology and Intensive Care

Investigators

  • Study Director: Jan Malaska, assoc. prof. MD., Ph.D., University Hospital Brno
  • Study Chair: Petr Stourac, prof.MD.Ph.D., Faculty of medicince Masaryk University and University Hospital Brno

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2021

Primary Completion (Actual)

June 14, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASAP-ESICM/ESAIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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