High- Versus Low-Dose Dexamethasone for the Treatment of COVID-19-related Acute Respiratory Distress Syndrome: A Multicenter and Randomized Open-label Clinical Trial
Abstract Purpose To determine whether high-dose dexamethasone increases the number of ventilator-free days (VFD) among patients with acute respiratory distress syndrome due to coronavirus disease 2019 (C-ARDS)Materials A multicenter randomized controlled trial in adults with C-ARDS. Patients received 16 mg/d of dexamethasone intravenously for five days followed by 8 mg/d of dexamethasone for five days, or 6 mg/d of dexamethasone intravenously for 10 days.Results Data from 98 patients who received at least one dose of dexamethasone were analyzed. At 28 days after randomization, there was no difference between high- and low-dose dexamethasone groups in VFD (median, 0 d [interquartile range (IQR) 0–14 d] versus 0 d [IQR 0–1 d]; P=0.231). The cumulative hazard of successful discontinuation from mechanical ventilation was increased by the high-dose treatment (adjusted sub-distribution hazard ratio: 1.84; 95% CI: 1.31 to 2.5; P<0.001). None of the prespecified secondary and safety outcomes showed a significant difference between treatment arms.Conclusions Among patients with C-ARDS, the use of higher doses of dexamethasone compared with the recommended low-dose treatment did not show an increase in VFD. However, the higher dose significantly improved the time required to liberate them from the ventilatorClinical Trial Registered: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04395105">NCT04395105</jats:ext-link>.
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Preprint| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
bioRxiv.org - (2022) vom: 25. Mai Zur Gesamtaufnahme - year:2022 |
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| Sprache: |
Englisch |
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| Beteiligte Personen: |
Maskin, Luis Patricio [VerfasserIn] |
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| Links: |
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| doi: |
10.1101/2021.09.15.21263597 |
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| PPN (Katalog-ID): |
XBI032626290 |
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| 520 | |a Abstract Purpose To determine whether high-dose dexamethasone increases the number of ventilator-free days (VFD) among patients with acute respiratory distress syndrome due to coronavirus disease 2019 (C-ARDS)Materials A multicenter randomized controlled trial in adults with C-ARDS. Patients received 16 mg/d of dexamethasone intravenously for five days followed by 8 mg/d of dexamethasone for five days, or 6 mg/d of dexamethasone intravenously for 10 days.Results Data from 98 patients who received at least one dose of dexamethasone were analyzed. At 28 days after randomization, there was no difference between high- and low-dose dexamethasone groups in VFD (median, 0 d [interquartile range (IQR) 0–14 d] versus 0 d [IQR 0–1 d]; P=0.231). The cumulative hazard of successful discontinuation from mechanical ventilation was increased by the high-dose treatment (adjusted sub-distribution hazard ratio: 1.84; 95% CI: 1.31 to 2.5; P<0.001). None of the prespecified secondary and safety outcomes showed a significant difference between treatment arms.Conclusions Among patients with C-ARDS, the use of higher doses of dexamethasone compared with the recommended low-dose treatment did not show an increase in VFD. However, the higher dose significantly improved the time required to liberate them from the ventilatorClinical Trial Registered: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04395105">NCT04395105</jats:ext-link> | ||
| 700 | 1 | |a Bonelli, Ignacio |e verfasserin |4 aut | |
| 700 | 1 | |a Olarte, Gabriel Leonardo |e verfasserin |4 aut | |
| 700 | 1 | |a Palizas, Fernando |e verfasserin |4 aut | |
| 700 | 1 | |a Velo, Agostina E |e verfasserin |4 aut | |
| 700 | 1 | |a Lurbet, María Fernanda |e verfasserin |4 aut | |
| 700 | 1 | |a Lovazzano, Pablo |e verfasserin |4 aut | |
| 700 | 1 | |a Kotsias, Sophia |e verfasserin |4 aut | |
| 700 | 1 | |a Attie, Shiry |e verfasserin |4 aut | |
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| 700 | 1 | |a Baredes, Natalio D |e verfasserin |4 aut | |
| 700 | 1 | |a Setten, Mariano |e verfasserin |4 aut | |
| 700 | 1 | |a Rodriguez, Pablo Oscar |e verfasserin |4 aut | |
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