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 | |
|---|---|
| Rok publikování | 2021 |
| Druh | Článek v odborném periodiku |
| Časopis / Zdroj | TRIALS |
| Fakulta / Pracoviště MU | |
| Citace | |
| www | https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-021-05116-9.pdf |
| Doi | http://dx.doi.org/10.1186/s13063-021-05116-9 |
| Klíčová slova | COVID-19; Randomised controlled trial; Protocol; ARDS; Dexamethasone; Ventilator-free days |
| Popis | 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. |
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