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.

Basic information

Original name

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

Authors

MALÁSKA, Jan (203 Czech Republic, guarantor, belonging to the institution), Jan STAŠEK (203 Czech Republic, belonging to the institution), Frantisek DUSKA (203 Czech Republic), Martin BALIK (203 Czech Republic), Jan MACA (203 Czech Republic), Jan HRUDA (203 Czech Republic, belonging to the institution), Tomáš VYMAZAL (203 Czech Republic), Olga KLEMENTOVA (203 Czech Republic), Jan ZATLOUKAL (203 Czech Republic), Tomas GABRHELIK (203 Czech Republic), Pavel NOVOTNY (203 Czech Republic), Regina DEMLOVÁ (203 Czech Republic, belonging to the institution), Jana KUBÁTOVÁ (203 Czech Republic, belonging to the institution), Jana VINKLEROVÁ (203 Czech Republic, belonging to the institution), Adam SVOBODNÍK (203 Czech Republic, belonging to the institution), Milan KRATOCHVÍL (703 Slovakia, belonging to the institution), Jozef KLUČKA (703 Slovakia, belonging to the institution), Roman GÁL (203 Czech Republic, belonging to the institution) and Mervyn SINGER

Edition

TRIALS, London, BMC, 2021, 1745-6215

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30304 Public and environmental health

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 2.728

RIV identification code

RIV/00216224:14110/21:00121476

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1186/s13063-021-05116-9

UT WoS

000625387800002

Keywords in English

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

Tags

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

Tags

International impact, Reviewed
Změněno: 17/5/2022 09:06, Mgr. Tereza Miškechová

Abstract

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.

Links

CZ.02.1.01/0.0/0.0/16_013/0001826, interní kód MU
(CEP code: EF16_013/0001826)
Name: CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií
Investor: Ministry of Education, Youth and Sports of the CR, Priority axis 1: Strengthening capacities for high-quality research
90128, large research infrastructures
Name: CZECRIN III
Displayed: 16/11/2024 03:04