Clinical trial NCT04866082: Corticosteroids in Severe COVID-19 (ASAP-ESICM/ESAIC Study)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe COVID-19
Keywords: COVID-19
ARDS
corticosteroids
critical care
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
name: European Society of Anaesthesiology and Intensive Care
First posted: 2021-04-29
Enrollment: 466
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members of European Society of Intensive Care Members of European Society of Anaesthesiology and Intensive Care (ESAIC)

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Administration of systemic corticosteroids among patients with COVID-19 ARDS practice in European countries - questionnaire (electronic survey)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
state: South Moravian Region
Study officials:
affiliation: University Hospital Brno
name: Jan Malaska, assoc. prof. MD., Ph.D.
role: STUDY_DIRECTOR
affiliation: Faculty of medicince Masaryk University and University Hospital Brno
name: Petr Stourac, prof.MD.Ph.D.
role: STUDY_CHAIR
References: