-
Something wrong with this record ?
Effects of two different dexamethasone dosing regimens on ventilator-free days and long-term mortality in COVID-19 patients with moderate-to-severe ARDS: the REMED randomized clinical trial
J. Maláska, J. Stašek, J. Máca, M. Kutěj, F. Duška, P. Kafka, O. Klementová, L. Doubravská, J. Hruda, M. Fencl, T. Gabrhelík, L. Číž, J. Zatloukal, J. Pouska, P. Novotný, M. Balík, R. Demlová, J. Kubátová, J. Vinklerová, K. Grodová, R. Štěpánová,...
Language English Country England, Great Britain
Document type Journal Article, Randomized Controlled Trial, Multicenter Study
NLK
BioMedCentral
from 2009-12-01
BioMedCentral Open Access
from 2009
Directory of Open Access Journals
from 2012
Free Medical Journals
from 2012
PubMed Central
from 2009
Europe PubMed Central
from 2009
ProQuest Central
from 2015-01-01
Open Access Digital Library
from 2009-01-01
Open Access Digital Library
from 2012-01-01
Medline Complete (EBSCOhost)
from 2015-06-01
Health & Medicine (ProQuest)
from 2015-01-01
ROAD: Directory of Open Access Scholarly Resources
from 1995
Springer Nature OA/Free Journals
from 2009-12-01
- MeSH
- COVID-19 * mortality complications MeSH
- Dexamethasone * administration & dosage therapeutic use MeSH
- COVID-19 Drug Treatment * MeSH
- Middle Aged MeSH
- Humans MeSH
- SARS-CoV-2 MeSH
- Aged MeSH
- Respiratory Distress Syndrome * drug therapy mortality MeSH
- Respiration, Artificial * MeSH
- Treatment Outcome MeSH
- Dose-Response Relationship, Drug MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Geographicals
- Czech Republic MeSH
BACKGROUND: Dexamethasone 6 mg in patients with severe COVID-19 has been shown to decrease mortality and morbidity. The effects of higher doses of corticosteroid, that would further increase anti-inflammatory effects, are uncertain. The objective of our study was to assess the effect of 20 mg dexamethasone vs. 6 mg dexamethasone intravenously in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) and COVID-19. METHODS: In a multicenter, open-label, randomized trial conducted in nine hospitals in the Czech Republic, we randomized adult patients with ARDS and COVID-19 requiring high-flow oxygen, noninvasive or invasive mechanical ventilation to receive either intravenous high-dose dexamethasone (20 mg/day on days 1-5, 10 mg/day on days 6-10) or standard-dose dexamethasone (6 mg/d, days 1-10). The primary outcome was 28-day ventilator-free days. The five secondary outcomes were 60-day mortality, C-reactive protein dynamics, 14-day WHO (World Health Organization) Clinical Progression Scale score, adverse events and 90-day Barthel index. The long-term outcomes were 180- and 360-day mortality and the Barthel index. The planned sample size was 300, with interim analysis after enrollment of 150 patients. RESULTS: The trial was stopped due to a lack of recruitment, and the follow-up was completed in February 2023. Among 234 randomized patients of 300 planned patients, the primary outcome was available for 224 patients (110 high-dose and 114 standard-dose dexamethasone; median [interquartile range (IQR)] age, 59.0 [48.5-66.0] years; 130 [58.0%] were receiving noninvasive or invasive mechanical ventilation at baseline). The mean number of 28-day ventilator-free days was 8.9 (± 11.5) days for high-dose dexamethasone and 8.0 (± 10.7) days for standard-dose dexamethasone, with an absolute difference of + 0.81 days (95% CI - 2.12-3.73 days). None of the prespecified secondary outcomes, including adverse events, differed between the groups. CONCLUSIONS: Despite not reaching its prespecified enrollment, there was no signal to either benefit or harm high-dose dexamethasone over standard-dose dexamethasone in patients with COVID-19 and moderate-to-severe ARDS. Trial registration Trial registration: ClinicalTrials.gov Identifier: NCT04663555. Registered 10 December 2020, https://clinicaltrials.gov/study/NCT04663555?term=NCT04663555&rank=1 and EudraCT: 2020-005887-70.
Department of Pharmacology CZECRIN Faculty of Medicine Masaryk University Brno Czech Republic
Department of Simulation Medicine Faculty of Medicine Masaryk University Brno Czech Republic
International Clinical Research Centre at St Anne's University Hospital Brno Czech Republic
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc25002977
- 003
- CZ-PrNML
- 005
- 20250206104005.0
- 007
- ta
- 008
- 250121s2024 enk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1186/s40001-024-02215-6 $2 doi
- 035 __
- $a (PubMed)39710693
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a enk
- 100 1_
- $a Maláska, Jan $u Department of Paediatric Anaesthesiology and Intensive Care Medicine, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic $u Department of Simulation Medicine, Faculty of Medicine, Masaryk University, Brno, Czech Republic $u Second Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic $u Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic
- 245 10
- $a Effects of two different dexamethasone dosing regimens on ventilator-free days and long-term mortality in COVID-19 patients with moderate-to-severe ARDS: the REMED randomized clinical trial / $c J. Maláska, J. Stašek, J. Máca, M. Kutěj, F. Duška, P. Kafka, O. Klementová, L. Doubravská, J. Hruda, M. Fencl, T. Gabrhelík, L. Číž, J. Zatloukal, J. Pouska, P. Novotný, M. Balík, R. Demlová, J. Kubátová, J. Vinklerová, K. Grodová, R. Štěpánová, A. Svobodník, M. Kratochvíl, J. Klučka, P. Štourač, M. Singer, REMED Study Group
- 520 9_
- $a BACKGROUND: Dexamethasone 6 mg in patients with severe COVID-19 has been shown to decrease mortality and morbidity. The effects of higher doses of corticosteroid, that would further increase anti-inflammatory effects, are uncertain. The objective of our study was to assess the effect of 20 mg dexamethasone vs. 6 mg dexamethasone intravenously in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) and COVID-19. METHODS: In a multicenter, open-label, randomized trial conducted in nine hospitals in the Czech Republic, we randomized adult patients with ARDS and COVID-19 requiring high-flow oxygen, noninvasive or invasive mechanical ventilation to receive either intravenous high-dose dexamethasone (20 mg/day on days 1-5, 10 mg/day on days 6-10) or standard-dose dexamethasone (6 mg/d, days 1-10). The primary outcome was 28-day ventilator-free days. The five secondary outcomes were 60-day mortality, C-reactive protein dynamics, 14-day WHO (World Health Organization) Clinical Progression Scale score, adverse events and 90-day Barthel index. The long-term outcomes were 180- and 360-day mortality and the Barthel index. The planned sample size was 300, with interim analysis after enrollment of 150 patients. RESULTS: The trial was stopped due to a lack of recruitment, and the follow-up was completed in February 2023. Among 234 randomized patients of 300 planned patients, the primary outcome was available for 224 patients (110 high-dose and 114 standard-dose dexamethasone; median [interquartile range (IQR)] age, 59.0 [48.5-66.0] years; 130 [58.0%] were receiving noninvasive or invasive mechanical ventilation at baseline). The mean number of 28-day ventilator-free days was 8.9 (± 11.5) days for high-dose dexamethasone and 8.0 (± 10.7) days for standard-dose dexamethasone, with an absolute difference of + 0.81 days (95% CI - 2.12-3.73 days). None of the prespecified secondary outcomes, including adverse events, differed between the groups. CONCLUSIONS: Despite not reaching its prespecified enrollment, there was no signal to either benefit or harm high-dose dexamethasone over standard-dose dexamethasone in patients with COVID-19 and moderate-to-severe ARDS. Trial registration Trial registration: ClinicalTrials.gov Identifier: NCT04663555. Registered 10 December 2020, https://clinicaltrials.gov/study/NCT04663555?term=NCT04663555&rank=1 and EudraCT: 2020-005887-70.
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 12
- $a COVID-19 $x mortalita $x komplikace $7 D000086382
- 650 12
- $a farmakoterapie COVID-19 $7 D000093485
- 650 12
- $a dexamethason $x aplikace a dávkování $x terapeutické užití $7 D003907
- 650 _2
- $a vztah mezi dávkou a účinkem léčiva $7 D004305
- 650 12
- $a umělé dýchání $7 D012121
- 650 12
- $a syndrom dechové tísně $x farmakoterapie $x mortalita $7 D012128
- 650 _2
- $a SARS-CoV-2 $7 D000086402
- 650 _2
- $a výsledek terapie $7 D016896
- 651 _2
- $a Česká republika $x epidemiologie $7 D018153
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a multicentrická studie $7 D016448
- 700 1_
- $a Stašek, Jan $u Department of Simulation Medicine, Faculty of Medicine, Masaryk University, Brno, Czech Republic $u Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic $u Department of Internal Medicine and Cardiology, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic
- 700 1_
- $a Máca, Jan $u Department of Anesthesiology and Intensive Care Medicine, University Hospital Ostrava and Faculty of Medicine, University Ostrava, Ostrava-Poruba, Czech Republic
- 700 1_
- $a Kutěj, Martin $u Department of Anesthesiology and Intensive Care Medicine, University Hospital Ostrava and Faculty of Medicine, University Ostrava, Ostrava-Poruba, Czech Republic
- 700 1_
- $a Duška, František $u Department of Anaesthesia and Intensive Care, University Hospital Královské Vinohrady and the Third Faculty of Medicine, Charles University, Šrobárova 1150, 10034, Praha, Czech Republic. fduska@yahoo.com
- 700 1_
- $a Kafka, Petr $u Department of Anaesthesia and Intensive Care, University Hospital Královské Vinohrady and the Third Faculty of Medicine, Charles University, Šrobárova 1150, 10034, Praha, Czech Republic
- 700 1_
- $a Klementová, Olga $u Department of Anaesthesiology and Intensive Care Medicine, University Hospital Olomouc and Faculty of Medicine, Palacky University, Olomouc, Czech Republic
- 700 1_
- $a Doubravská, Lenka $u Department of Anaesthesiology and Intensive Care Medicine, University Hospital Olomouc and Faculty of Medicine, Palacky University, Olomouc, Czech Republic
- 700 1_
- $a Hruda, Jan $u Department of Anaesthesiology and Intensive Care Medicine, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czech Republic $u International Clinical Research Centre (ICRC) at St. Anne's University Hospital, Brno, Czech Republic
- 700 1_
- $a Fencl, Marek $u Department of Anaesthesiology and Intensive Care Medicine, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czech Republic $u International Clinical Research Centre (ICRC) at St. Anne's University Hospital, Brno, Czech Republic
- 700 1_
- $a Gabrhelík, Tomáš $u Department of Anaesthesiology and Intensive Care Medicine, Tomáš Baťa Regional Hospital, Zlín, Czech Republic
- 700 1_
- $a Číž, Libor $u Department of Anaesthesiology and Intensive Care Medicine, Tomáš Baťa Regional Hospital, Zlín, Czech Republic
- 700 1_
- $a Zatloukal, Jan $u Department of Anaesthesiology and Intensive Care Medicine, University Hospital Pilsen and Faculty of Medicine in Pilsen, Charles University, Plzeň, Czech Republic
- 700 1_
- $a Pouska, Jiří $u Department of Anaesthesiology and Intensive Care Medicine, University Hospital Pilsen and Faculty of Medicine in Pilsen, Charles University, Plzeň, Czech Republic
- 700 1_
- $a Novotný, Pavel $u Department of Anaesthesiology and Intensive Care, Military University Hospital Praha and the First Faculty of Medicine Charles University, Prague, Czech Republic
- 700 1_
- $a Balík, Martin $u Department of Anaesthesia and Intensive Care, General University Hospital in Prague and the First Faculty of Medicine, Charles University, Prague, Czech Republic
- 700 1_
- $a Demlová, Regina $u Department of Pharmacology/CZECRIN, Faculty of Medicine, Masaryk University, Brno, Czech Republic
- 700 1_
- $a Kubátová, Jana $u Department of Pharmacology/CZECRIN, Faculty of Medicine, Masaryk University, Brno, Czech Republic
- 700 1_
- $a Vinklerová, Jana $u Department of Pharmacology/CZECRIN, Faculty of Medicine, Masaryk University, Brno, Czech Republic
- 700 1_
- $a Grodová, Karolína $u Department of Pharmacology/CZECRIN, Faculty of Medicine, Masaryk University, Brno, Czech Republic
- 700 1_
- $a Štěpánová, Radka $u Department of Pharmacology/CZECRIN, Faculty of Medicine, Masaryk University, Brno, Czech Republic
- 700 1_
- $a Svobodník, Adam $u Department of Pharmacology/CZECRIN, Faculty of Medicine, Masaryk University, Brno, Czech Republic
- 700 1_
- $a Kratochvíl, Milan $u Department of Paediatric Anaesthesiology and Intensive Care Medicine, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic
- 700 1_
- $a Klučka, Jozef $u Department of Paediatric Anaesthesiology and Intensive Care Medicine, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic
- 700 1_
- $a Štourač, Petr $u Department of Paediatric Anaesthesiology and Intensive Care Medicine, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic $u Department of Simulation Medicine, Faculty of Medicine, Masaryk University, Brno, Czech Republic
- 700 1_
- $a Singer, Mervyn $u Bloomsbury Institute of Intensive Care Medicine, Division of Medicine, University College London, London, UK
- 710 2_
- $a REMED Study Group
- 773 0_
- $w MED00181709 $t European journal of medical research $x 2047-783X $g Roč. 29, č. 1 (2024), s. 616
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/39710693 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20250121 $b ABA008
- 991 __
- $a 20250206104001 $b ABA008
- 999 __
- $a ok $b bmc $g 2263026 $s 1238984
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2024 $b 29 $c 1 $d 616 $e 20241223 $i 2047-783X $m European journal of medical research $n Eur J Med Res $x MED00181709
- LZP __
- $a Pubmed-20250121
