Effects of two different dexamethasone dosing regimens on
ventilator-free days and long-term mortality in COVID-19
patients with moderate-to-severe ARDS: the REMED randomized
clinical trial

J 2024

Effects of two different dexamethasone dosing regimens on ventilator-free days and long-term mortality in COVID-19 patients with moderate-to-severe ARDS: the REMED randomized clinical trial

MALÁSKA, Jan; Jan STAŠEK; Jan MACA; Martin KUTĚJ; Frantisek DUSKA et. al.

Basic information

Original name

Effects of two different dexamethasone dosing regimens on ventilator-free days and long-term mortality in COVID-19 patients with moderate-to-severe ARDS: the REMED randomized clinical trial

Authors

Edition

European Journal of Medical Research, London, Biomed Central, 2024, 0949-2321

Other information

Language

English

Type of outcome

Article in a journal

Field of Study

30223 Anaesthesiology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

is not subject to a state or trade secret

References:

URL

Impact factor

Impact factor: 3.400

RIV identification code

RIV/00216224:14110/24:00138213

Organization unit

Faculty of Medicine

DOI

https://doi.org/10.1186/s40001-024-02215-6

UT WoS

001381969300007

EID Scopus

2-s2.0-85214184335

Keywords (in Czech)

COVID-19; ARDS; Dexamethasone; Randomized clinical trial; Ventilator-free days; Long-term outcomes

Keywords in English

COVID-19; ARDS; Dexamethasone; Randomized clinical trial; Ventilator-free days; Long-term outcomes

Abstract

In the original language

Dexamethasone 6 mg in patients with severe COVID-19 has been shown to decrease mortality and morbidity. The effects of higher doses of corticosteroid, that would further increase anti-inflammatory effects, are uncertain. The objective of our study was to assess the effect of 20 mg dexamethasone vs. 6 mg dexamethasone intravenously in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) and COVID-19.MethodsIn a multicenter, open-label, randomized trial conducted in nine hospitals in the Czech Republic, we randomized adult patients with ARDS and COVID-19 requiring high-flow oxygen, noninvasive or invasive mechanical ventilation to receive either intravenous high-dose dexamethasone (20 mg/day on days 1-5, 10 mg/day on days 6-10) or standard-dose dexamethasone (6 mg/d, days 1-10). The primary outcome was 28-day ventilator-free days. The five secondary outcomes were 60-day mortality, C-reactive protein dynamics, 14-day WHO (World Health Organization) Clinical Progression Scale score, adverse events and 90-day Barthel index. The long-term outcomes were 180- and 360-day mortality and the Barthel index. The planned sample size was 300, with interim analysis after enrollment of 150 patients. https://clinicaltrials.gov/study/NCT04663555?term=NCT04663555&rank=1 and EudraCT: 2020-005887-70.

Links

90249, large research infrastructures

Name: CZECRIN IV

Cite

MALÁSKA, Jan; Jan STAŠEK; Jan MACA; Martin KUTĚJ; Frantisek DUSKA; Petr KAFKA; Olga KLEMENTOVA; Lenka DOUBRAVSKA; Jan HRUDA; Marek FENCL; Tomas GABRHELIK; Libor CIZ; Jan ZATLOUKAL; Jiri POUSKA; Pavel NOVOTNY; Martin BALIK; Regina DEMLOVÁ; Jana KUBÁTOVÁ; Jana UNAR VINKLEROVÁ; Karolína GRODOVÁ; Radka ŠTĚPÁNOVÁ; Adam SVOBODNÍK; Milan KRATOCHVÍL; Jozef KLUČKA; Petr ŠTOURAČ and Mervyn SINGER. Effects of two different dexamethasone dosing regimens on ventilator-free days and long-term mortality in COVID-19 patients with moderate-to-severe ARDS: the REMED randomized clinical trial. European Journal of Medical Research. London: Biomed Central, 2024, vol. 29, No 1, p. 1-11. ISSN 0949-2321. Available from: https://doi.org/10.1186/s40001-024-02215-6.

@article{2464278,
   author = {Maláska, Jan and Stašek, Jan and Maca, Jan and Kutěj, Martin and Duska, Frantisek and Kafka, Petr and Klementova, Olga and Doubravska, Lenka and Hruda, Jan and Fencl, Marek and Gabrhelik, Tomas and Ciz, Libor and Zatloukal, Jan and Pouska, Jiri and Novotny, Pavel and Balik, Martin and Demlová, Regina and Kubátová, Jana and Unar Vinklerová, Jana and Grodová, Karolína and Štěpánová, Radka and Svobodník, Adam and Kratochvíl, Milan and Klučka, Jozef and Štourač, Petr and Singer, Mervyn},
   article_location = {London},
   article_number = {1},
   doi = {https://doi.org/10.1186/s40001-024-02215-6},
   keywords = {COVID-19; ARDS; Dexamethasone; Randomized clinical trial; Ventilator-free days; Long-term outcomes},
   language = {eng},
   issn = {0949-2321},
   journal = {European Journal of Medical Research},
   title = {Effects of two different dexamethasone dosing regimens on ventilator-free days and long-term mortality in COVID-19 patients with moderate-to-severe ARDS: the REMED randomized clinical trial},
   url = {https://eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-02215-6},
   volume = {29},
   year = {2024}
}

TY  - JOUR
ID  - 2464278
AU  - Maláska, Jan - Stašek, Jan - Maca, Jan - Kutěj, Martin - Duska, Frantisek - Kafka, Petr - Klementova, Olga - Doubravska, Lenka - Hruda, Jan - Fencl, Marek - Gabrhelik, Tomas - Ciz, Libor - Zatloukal, Jan - Pouska, Jiri - Novotny, Pavel - Balik, Martin - Demlová, Regina - Kubátová, Jana - Unar Vinklerová, Jana - Grodová, Karolína - Štěpánová, Radka - Svobodník, Adam - Kratochvíl, Milan - Klučka, Jozef - Štourač, Petr - Singer, Mervyn
PY  - 2024
TI  - Effects of two different dexamethasone dosing regimens on ventilator-free days and long-term mortality in COVID-19 patients with moderate-to-severe ARDS: the REMED randomized clinical trial
JF  - European Journal of Medical Research
VL  - 29
IS  - 1
SP  - 1-11
EP  - 1-11
PB  - Biomed Central
SN  - 09492321
KW  - COVID-19
KW  - ARDS
KW  - Dexamethasone
KW  - Randomized clinical trial
KW  - Ventilator-free days
KW  - Long-term outcomes
UR  - https://eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-02215-6
N2  - Dexamethasone 6 mg in patients with severe COVID-19 has been shown to decrease mortality and morbidity. The effects of higher doses of corticosteroid, that would further increase anti-inflammatory effects, are uncertain. The objective of our study was to assess the effect of 20 mg dexamethasone vs. 6 mg dexamethasone intravenously in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) and COVID-19.MethodsIn a multicenter, open-label, randomized trial conducted in nine hospitals in the Czech Republic, we randomized adult patients with ARDS and COVID-19 requiring high-flow oxygen, noninvasive or invasive mechanical ventilation to receive either intravenous high-dose dexamethasone (20 mg/day on days 1-5, 10 mg/day on days 6-10) or standard-dose dexamethasone (6 mg/d, days 1-10). The primary outcome was 28-day ventilator-free days. The five secondary outcomes were 60-day mortality, C-reactive protein dynamics, 14-day WHO (World Health Organization) Clinical Progression Scale score, adverse events and 90-day Barthel index. The long-term outcomes were 180- and 360-day mortality and the Barthel index. The planned sample size was 300, with interim analysis after enrollment of 150 patients. https://clinicaltrials.gov/study/NCT04663555?term=NCT04663555&rank=1 and EudraCT: 2020-005887-70.
ER  -

MALÁSKA, Jan; Jan STAŠEK; Jan MACA; Martin KUTĚJ; Frantisek DUSKA; Petr KAFKA; Olga KLEMENTOVA; Lenka DOUBRAVSKA; Jan HRUDA; Marek FENCL; Tomas GABRHELIK; Libor CIZ; Jan ZATLOUKAL; Jiri POUSKA; Pavel NOVOTNY; Martin BALIK; Regina DEMLOVÁ; Jana KUBÁTOVÁ; Jana UNAR VINKLEROVÁ; Karolína GRODOVÁ; Radka ŠTĚPÁNOVÁ; Adam SVOBODNÍK; Milan KRATOCHVÍL; Jozef KLUČKA; Petr ŠTOURAČ and Mervyn SINGER. Effects of two different dexamethasone dosing regimens on ventilator-free days and long-term mortality in COVID-19 patients with moderate-to-severe ARDS: the REMED randomized clinical trial. \textit{European Journal of Medical Research}. London: Biomed Central, 2024, vol.~29, No~1, p.~1-11. ISSN~0949-2321. Available from: https://doi.org/10.1186/s40001-024-02215-6.

Přehled o publikaci