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.

Základní údaje

Originální název

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

Autoři

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30223 Anaesthesiology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 3.400

Kód RIV

RIV/00216224:14110/24:00138213

Organizační jednotka

Lékařská fakulta

DOI

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

UT WoS

001381969300007

EID Scopus

2-s2.0-85214184335

Klíčová slova česky

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

Klíčová slova anglicky

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

Štítky

14110122, 14110211, 14110233, 14110322, 14110516, 14110528, CZECRIN, Excelence Science, FN Brno, LF MU Brno, RIV, rivok, user, článek v časopise

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 17. 3. 2025 09:20, Mgr. Tereza Miškechová

Anotace

V originále

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.

Návaznosti

90249, velká výzkumná infrastruktura

Název: CZECRIN IV

Citovat

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 a 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, roč. 29, č. 1, s. 1-11. ISSN 0949-2321. Dostupné z: 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 a 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, roč.~29, č.~1, s.~1-11. ISSN~0949-2321. Dostupné z: https://doi.org/10.1186/s40001-024-02215-6.

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