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Randomized Controlled Trial
. 2022 Apr;37(4):491-499.
doi: 10.1177/08850666211066799. Epub 2021 Dec 13.

High- Versus Low-Dose Dexamethasone for the Treatment of COVID-19-Related Acute Respiratory Distress Syndrome: A Multicenter, Randomized Open-Label Clinical Trial

Luis Patricio Maskin  1   2 , Ignacio Bonelli  3 , Gabriel Leonardo Olarte  4 , Fernando Palizas Jr  5 , Agostina E Velo  1   3 , María Fernanda Lurbet  1   3 , Pablo Lovazzano  3 , Sophia Kotsias  1 , Shiry Attie  3 , Ignacio Lopez Saubidet  3 , Natalio D Baredes  4 , Mariano Setten  1 , Pablo Oscar Rodriguez  1   2
Affiliations
Randomized Controlled Trial

High- Versus Low-Dose Dexamethasone for the Treatment of COVID-19-Related Acute Respiratory Distress Syndrome: A Multicenter, Randomized Open-Label Clinical Trial

Luis Patricio Maskin et al. J Intensive Care Med. 2022 Apr.

Abstract

Objective: To determine whether high-dose dexamethasone increases the number of ventilator-free days (VFD) among patients with acute respiratory distress syndrome (ARDS) caused by COVID-19.

Design: Multicenter, randomized, open-label, clinical trial.

Participants: Consecutive patients with confirmed COVID-19-related ARDS were enrolled from June 17, 2020, to March 27, 2021, in four intensive care units (ICUs) in Argentina.

Intervention: 16 mg of dexamethasone intravenously daily for five days followed by 8 mg of dexamethasone daily for five days or 6 mg of dexamethasone intravenously daily for 10 days.

Main outcome and measures: The primary outcome was ventilator-free days during the first 28 days. The secondary outcomes were all-cause mortality at 28 and 90 days, infection rate, muscle weakness, and glycemic control in the first 28 days.

Results: Data from 98 patients who received at least one dose of dexamethasone were analyzed. The trial was prematurely terminated due to low enrollment rate. At 28 days after randomization, there was no difference between high- and low-dose dexamethasone groups in VFD (median, 0 [interquartile range [IQR] 0-14] vs. 0 [IQR 0-1] days; P = .231), or in the mean duration of mechanical ventilation (19 ± 18 vs. 25 ± 22 days; P = .078). 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 < .001). None of the prespecified secondary and safety outcomes showed a significant difference between treatment arms.

Conclusions: Among patients with ARDS due to COVID-19, 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 ventilator.

Keywords: acute respiratory distress syndrome; coronavirus; dexamethasone; randomized controlled trial; viral pneumonia.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Flow diagram of the study.
Figure 2.
Figure 2.
Probability of the successful discontinuation of mechanical ventilation or death within 28 days of the randomization.
See this image and copyright information in PMC

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