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 and 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, vol. 22, No 1, p. 1-4. ISSN 1745-6215. Available from: https://dx.doi.org/10.1186/s13063-021-05116-9.
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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
Original language English
Type of outcome Article in a journal
Field of Study 30304 Public and environmental health
Country of publisher United Kingdom of Great Britain and Northern Ireland
Confidentiality degree is not subject to a state or trade secret
WWW 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
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 17/5/2022 09:06.
Abstract
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 infrastructuresName: CZECRIN III
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