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 triall

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F22%3A73616945" target="_blank" >RIV/61989592:15110/22:73616945 - isvavai.cz</a>

Výsledek na webu

<a href="https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05963-6" target="_blank" >https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05963-6</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1186/s13063-021-05963-6" target="_blank" >10.1186/s13063-021-05963-6</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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 triall

Popis výsledku v původním jazyce

AbstractBackground: Since December 2019, SARS-CoV-2 virus has infected millions of people worldwide. In patients withCOVID-19 pneumonia in need of oxygen therapy or mechanical ventilation, dexamethasone 6 mg per day iscurrently recommended. However, the dose of 6 mg of dexamethasone is currently being reappraised and maymiss 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 20mg (dexamethasone 20 mg on days 1–5, followed by dexamethasone 10 mg on days 6–10) vs 6 mg administeredonce daily intravenously for 10 days in adult patients with moderate or severe ARDS due to confirmed COVID-19. Threehundred participants will be enrolled and followed up for 360 days after randomization. Patients will be randomised ina 1:1 ratio into one of the two treatment arms. The following stratification factors will be applied: age, CharlsonComorbidity Index, CRP levels and trial centre. The primary endpoint is the number of ventilator-free days (VFDs) at 28days 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 relatedto corticosteroids and independence at 90 days after randomisation assessed by the Barthel Index. The long-termoutcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days. Thestudy 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 ARDSundergoing mechanical ventilation regarding efficacy and safety

Název v anglickém jazyce

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 triall

Popis výsledku anglicky

AbstractBackground: Since December 2019, SARS-CoV-2 virus has infected millions of people worldwide. In patients withCOVID-19 pneumonia in need of oxygen therapy or mechanical ventilation, dexamethasone 6 mg per day iscurrently recommended. However, the dose of 6 mg of dexamethasone is currently being reappraised and maymiss 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 20mg (dexamethasone 20 mg on days 1–5, followed by dexamethasone 10 mg on days 6–10) vs 6 mg administeredonce daily intravenously for 10 days in adult patients with moderate or severe ARDS due to confirmed COVID-19. Threehundred participants will be enrolled and followed up for 360 days after randomization. Patients will be randomised ina 1:1 ratio into one of the two treatment arms. The following stratification factors will be applied: age, CharlsonComorbidity Index, CRP levels and trial centre. The primary endpoint is the number of ventilator-free days (VFDs) at 28days 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 relatedto corticosteroids and independence at 90 days after randomisation assessed by the Barthel Index. The long-termoutcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days. Thestudy 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 ARDSundergoing mechanical ventilation regarding efficacy and safety

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30223 - Anaesthesiology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Trials

ISSN

1745-6215

e-ISSN

1745-6215

Svazek periodika

23

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

15

Strana od-do

35

Kód UT WoS článku

000742915900005

EID výsledku v databázi Scopus

2-s2.0-85123119609