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

J 2022

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

Autoři

MALÁSKA, Jan (203 Česká republika, domácí), Jan STAŠEK (203 Česká republika, garant, domácí), Frantisek DUSKA (203 Česká republika), Martin BALIK (203 Česká republika), Jan MACA (203 Česká republika), Jan HRUDA (203 Česká republika, domácí), Tomas VYMAZAL (203 Česká republika), Olga KLEMENTOVA (203 Česká republika), Jan ZATLOUKAL (203 Česká republika), Tomas GABRHELIK (203 Česká republika), Pavel NOVOTNY (203 Česká republika), Regina DEMLOVÁ (203 Česká republika, domácí), Jana KUBÁTOVÁ (203 Česká republika, domácí), Jana UNAR VINKLEROVÁ (203 Česká republika, domácí), Adam SVOBODNÍK (203 Česká republika, domácí), Milan KRATOCHVÍL (703 Slovensko, domácí), Jozef KLUČKA (703 Slovensko, domácí), Roman GÁL (203 Česká republika, domácí) a Mervyn SINGER

Vydání

Trials, London, BMC, 2022, 1745-6215

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30221 Critical care medicine and Emergency medicine

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 2.500

Kód RIV

RIV/00216224:14110/22:00125258

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1186/s13063-021-05963-6

UT WoS

000742915900005

Klíčová slova anglicky

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

Štítky

14110122, 14110233, 14110322, 14110516, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 10. 2. 2022 14:20, Mgr. Tereza Miškechová

Anotace

V originále

Background: Since December 2019, SARS-CoV-2 virus has infected millions of people worldwide. In patients with COVID-19 pneumonia in need of oxygen therapy or mechanical ventilation, dexamethasone 6 mg per day is currently recommended. However, the dose of 6 mg of dexamethasone is currently being reappraised and may miss important therapeutic potential or may prevent potential deleterious effects of higher doses of corticosteroids. Methods: REMED is a prospective, open-label, randomised controlled trial testing the superiority of dexamethasone 20 mg (dexamethasone 20 mg on days 1-5, followed by dexamethasone 10 mg on days 6-10) vs 6 mg administered once daily intravenously for 10 days in adult patients with moderate or severe ARDS due to confirmed COVID-19. Three hundred participants will be enrolled and followed up for 360 days after randomization. Patients will be randomised in a 1:1 ratio into one of the two treatment arms. The following stratification factors will be applied: age, Charlson Comorbidity Index, CRP levels and trial centre. The primary endpoint is the number of ventilator-free days (VFDs) at 28 days after randomisation. The secondary endpoints are mortality from any cause at 60 days after randomisation; dynamics of the inflammatory marker, change in WHO Clinical Progression Scale at day 14; and adverse events related to corticosteroids and independence at 90 days after randomisation assessed by the Barthel Index. The long-term outcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days. The study will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. Discussion: We aim to compare two different doses of dexamethasone in patients with moderate to severe ARDS undergoing mechanical ventilation regarding efficacy and safety.

Návaznosti

LM2018128, projekt VaV

Název: Český národní uzel Evropské sítě infrastruktur klinického výzkumu (Akronym: CZECRIN)

Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, Český národní uzel Evropské sítě infrastruktur klinického výzkumu (CZECRIN)

Citovat

MALÁSKA, Jan, Jan STAŠEK, Frantisek DUSKA, Martin BALIK, Jan MACA, Jan HRUDA, Tomas VYMAZAL, Olga KLEMENTOVA, Jan ZATLOUKAL, Tomas GABRHELIK, Pavel NOVOTNY, Regina DEMLOVÁ, Jana KUBÁTOVÁ, Jana UNAR VINKLEROVÁ, Adam SVOBODNÍK, Milan KRATOCHVÍL, Jozef KLUČKA, Roman GÁL a Mervyn SINGER. Effect of dexamethasone in patients with ARDS and COVID-19 (REMED trial)-study protocol for a prospective, multi-centre, open-label, parallel-group, randomized controlled trial. Trials. London: BMC, 2022, roč. 23, č. 1, s. 1-15. ISSN 1745-6215. Dostupné z: https://dx.doi.org/10.1186/s13063-021-05963-6.

@article{1826910,
   author = {Maláska, Jan and Stašek, Jan and Duska, Frantisek and Balik, Martin and Maca, Jan and Hruda, Jan and Vymazal, Tomas and Klementova, Olga and Zatloukal, Jan and Gabrhelik, Tomas and Novotny, Pavel and Demlová, Regina and Kubátová, Jana and Unar Vinklerová, Jana and Svobodník, Adam and Kratochvíl, Milan and Klučka, Jozef and Gál, Roman and Singer, Mervyn},
   article_location = {London},
   article_number = {1},
   doi = {http://dx.doi.org/10.1186/s13063-021-05963-6},
   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 (REMED trial)-study protocol for a prospective, multi-centre, open-label, parallel-group, randomized controlled trial},
   url = {https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05963-6},
   volume = {23},
   year = {2022}
}

TY  - JOUR
ID  - 1826910
AU  - Maláska, Jan - Stašek, Jan - Duska, Frantisek - Balik, Martin - Maca, Jan - Hruda, Jan - Vymazal, Tomas - Klementova, Olga - Zatloukal, Jan - Gabrhelik, Tomas - Novotny, Pavel - Demlová, Regina - Kubátová, Jana - Unar Vinklerová, Jana - Svobodník, Adam - Kratochvíl, Milan - Klučka, Jozef - Gál, Roman - Singer, Mervyn
PY  - 2022
TI  - Effect of dexamethasone in patients with ARDS and COVID-19 (REMED trial)-study protocol for a prospective, multi-centre, open-label, parallel-group, randomized controlled trial
JF  - Trials
VL  - 23
IS  - 1
SP  - 1-15
EP  - 1-15
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/articles/10.1186/s13063-021-05963-6
N2  - Background: Since December 2019, SARS-CoV-2 virus has infected millions of people worldwide. In patients with COVID-19 pneumonia in need of oxygen therapy or mechanical ventilation, dexamethasone 6 mg per day is currently recommended. However, the dose of 6 mg of dexamethasone is currently being reappraised and may miss important therapeutic potential or may prevent potential deleterious effects of higher doses of corticosteroids. Methods: REMED is a prospective, open-label, randomised controlled trial testing the superiority of dexamethasone 20 mg (dexamethasone 20 mg on days 1-5, followed by dexamethasone 10 mg on days 6-10) vs 6 mg administered once daily intravenously for 10 days in adult patients with moderate or severe ARDS due to confirmed COVID-19. Three hundred participants will be enrolled and followed up for 360 days after randomization. Patients will be randomised in a 1:1 ratio into one of the two treatment arms. The following stratification factors will be applied: age, Charlson Comorbidity Index, CRP levels and trial centre. The primary endpoint is the number of ventilator-free days (VFDs) at 28 days after randomisation. The secondary endpoints are mortality from any cause at 60 days after randomisation; dynamics of the inflammatory marker, change in WHO Clinical Progression Scale at day 14; and adverse events related to corticosteroids and independence at 90 days after randomisation assessed by the Barthel Index. The long-term outcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days. The study will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. Discussion: We aim to compare two different doses of dexamethasone in patients with moderate to severe ARDS undergoing mechanical ventilation regarding efficacy and safety.
ER  -

MALÁSKA, Jan, Jan STAŠEK, Frantisek DUSKA, Martin BALIK, Jan MACA, Jan HRUDA, Tomas VYMAZAL, Olga KLEMENTOVA, Jan ZATLOUKAL, Tomas GABRHELIK, Pavel NOVOTNY, Regina DEMLOVÁ, Jana KUBÁTOVÁ, Jana UNAR VINKLEROVÁ, Adam SVOBODNÍK, Milan KRATOCHVÍL, Jozef KLUČKA, Roman GÁL a Mervyn SINGER. Effect of dexamethasone in patients with ARDS and COVID-19 (REMED trial)-study protocol for a prospective, multi-centre, open-label, parallel-group, randomized controlled trial. \textit{Trials}. London: BMC, 2022, roč.~23, č.~1, s.~1-15. ISSN~1745-6215. Dostupné z: https://dx.doi.org/10.1186/s13063-021-05963-6.

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