Effect of dexamethasone in patients with ARDS and
COVID-19-prospective, multi-centre, open-label, parallel-group,
randomised controlled trial (REMED trial): A structured summary
of a study protocol for a randomised controlled trial

J 2021

Effect of dexamethasone in patients with ARDS and COVID-19-prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial

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

Základní údaje

Originální název

Effect of dexamethasone in patients with ARDS and COVID-19-prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial

Autoři

Vydání

TRIALS, London, BMC, 2021, 1745-6215

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30304 Public and environmental health

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 2.728

Kód RIV

RIV/00216224:14110/21:00121476

Organizační jednotka

Lékařská fakulta

DOI

https://doi.org/10.1186/s13063-021-05116-9

UT WoS

000625387800002

EID Scopus

2-s2.0-85101940925

Klíčová slova anglicky

COVID-19; Randomised controlled trial; Protocol; ARDS; Dexamethasone; Ventilator-free days

Štítky

14110122, 14110233, 14110322, 14110516, Excelence Science, FN Brno, MU, operator, RIV, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 17. 5. 2022 09:06, Mgr. Tereza Miškechová

Anotace

V originále

Objectives: The primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days. Trial design: REMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pragmatic, i.e. designed to evaluate the effectiveness of the intervention in conditions that are close to real-life routine clinical practice. Participants: The study is multi-centre and will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic.

Návaznosti

CZ.02.1.01/0.0/0.0/16_013/0001826, interní kód MU
(Kód CEP: EF16_013/0001826)

Název: CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií

Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií, PO 1 Posilování kapacit pro kvalitní výzkum

90128, velká výzkumná infrastruktura

Název: CZECRIN III

Citovat

MALÁSKA, Jan; Jan STAŠEK; Frantisek DUSKA; Martin BALIK; Jan MACA; Jan HRUDA; Tomáš VYMAZAL; Olga KLEMENTOVA; Jan ZATLOUKAL; Tomas GABRHELIK; Pavel NOVOTNY; Regina DEMLOVÁ; Jana KUBÁTOVÁ; Jana VINKLEROVÁ; Adam SVOBODNÍK; Milan KRATOCHVÍL; Jozef KLUČKA; Roman GÁL a Mervyn SINGER. Effect of dexamethasone in patients with ARDS and COVID-19-prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial. TRIALS. London: BMC, 2021, roč. 22, č. 1, s. 1-4. ISSN 1745-6215. Dostupné z: https://doi.org/10.1186/s13063-021-05116-9.

@article{1763437,
   author = {Maláska, Jan and Stašek, Jan and Duska, Frantisek and Balik, Martin and Maca, Jan and Hruda, Jan and Vymazal, Tomáš and Klementova, Olga and Zatloukal, Jan and Gabrhelik, Tomas and Novotny, Pavel and Demlová, Regina and Kubátová, Jana and Vinklerová, Jana and Svobodník, Adam and Kratochvíl, Milan and Klučka, Jozef and Gál, Roman and Singer, Mervyn},
   article_location = {London},
   article_number = {1},
   doi = {https://doi.org/10.1186/s13063-021-05116-9},
   keywords = {COVID-19; Randomised controlled trial; Protocol; ARDS; Dexamethasone; Ventilator-free days},
   language = {eng},
   issn = {1745-6215},
   journal = {TRIALS},
   note = {REMED},
   title = {Effect of dexamethasone in patients with ARDS and COVID-19-prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial},
   url = {https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-021-05116-9.pdf},
   volume = {22},
   year = {2021}
}

TY  - JOUR
ID  - 1763437
AU  - Maláska, Jan - Stašek, Jan - Duska, Frantisek - Balik, Martin - Maca, Jan - Hruda, Jan - Vymazal, Tomáš - Klementova, Olga - Zatloukal, Jan - Gabrhelik, Tomas - Novotny, Pavel - Demlová, Regina - Kubátová, Jana - Vinklerová, Jana - Svobodník, Adam - Kratochvíl, Milan - Klučka, Jozef - Gál, Roman - Singer, Mervyn
PY  - 2021
TI  - Effect of dexamethasone in patients with ARDS and COVID-19-prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial
JF  - TRIALS
VL  - 22
IS  - 1
SP  - 1-4
EP  - 1-4
PB  - BMC
SN  - 17456215
N1  - REMED
KW  - COVID-19
KW  - Randomised controlled trial
KW  - Protocol
KW  - ARDS
KW  - Dexamethasone
KW  - Ventilator-free days
UR  - https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-021-05116-9.pdf
N2  - Objectives: The primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days. Trial design: REMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pragmatic, i.e. designed to evaluate the effectiveness of the intervention in conditions that are close to real-life routine clinical practice. Participants: The study is multi-centre and will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic.
ER  -

MALÁSKA, Jan; Jan STAŠEK; Frantisek DUSKA; Martin BALIK; Jan MACA; Jan HRUDA; Tomáš VYMAZAL; Olga KLEMENTOVA; Jan ZATLOUKAL; Tomas GABRHELIK; Pavel NOVOTNY; Regina DEMLOVÁ; Jana KUBÁTOVÁ; Jana VINKLEROVÁ; Adam SVOBODNÍK; Milan KRATOCHVÍL; Jozef KLUČKA; Roman GÁL a Mervyn SINGER. Effect of dexamethasone in patients with ARDS and COVID-19-prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial. \textit{TRIALS}. London: BMC, 2021, roč.~22, č.~1, s.~1-4. ISSN~1745-6215. Dostupné z: https://doi.org/10.1186/s13063-021-05116-9.

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