NCT04866082

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
466

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 30, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

April 26, 2021

Last Update Submit

February 21, 2023

Conditions

Keywords

COVID-19ARDScorticosteroidscritical care

Outcome Measures

Primary Outcomes (1)

  • Administration of systemic corticosteroids among patients with COVID-19 ARDS practice in European countries - questionnaire (electronic survey)

    Electronic survey will be send to the European Society of intensive care (ESICM) members via email

    2 months

Study Arms (1)

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

Interventions

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

Also known as: electronic survey
ESICM and ESAIC members

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • not members of European Society of Intensive Care (ESICM)
  • not members of European Society of Anaesthesiology and Intensive Care (ESAIC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

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

    University Hospital Brno

    STUDY DIRECTOR
  • Petr Stourac, prof.MD.Ph.D.

    Faculty of medicince Masaryk University and University Hospital Brno

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc.prof.MD,Ph.D

Study Record Dates

First Submitted

April 26, 2021

First Posted

April 29, 2021

Study Start

May 30, 2021

Primary Completion

June 14, 2022

Study Completion

June 30, 2022

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations