ROSE RCT – Early Paralytics For ARDS

June 20, 2019

Written by Clay Smith

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Early use of a paralytic infusion with deeper sedation did not reduce 90-day mortality in patients with ARDS compared to patients managed with lighter sedation and no paralytics.

Why does this matter?
Use of paralytic agents in ARDS may help with, “patient–ventilator dyssynchrony, the work of breathing, and the accumulation of alveolar fluid…However, prolonged administration of neuromuscular blocking agents is associated with subsequent neuromuscular weakness.” ACURASYS found paralytics were of benefit, but ventilatory strategies have markedly changed since then. What did this reevaluation find?

No paralysis of analysis here
ROSE – Reevaluation of Systemic Early Neuromuscular Blockade – was a large, multicenter randomized controlled trial of 1006 patients with moderate to severe ARDS who either had deeper sedation + an infusion of cisatracurium or lighter sedation and no paralytics. Patient cohorts were well matched and had identical ventilation strategies. The trial was stopped early after interim analysis found futility of continuing. Mortality at 90 days was 42.5% in the paralytic group and 42.8% in the controls, no statistical difference. More patients had ICU-related weakness at day 28 in the paralytic group, and there were also more serious cardiovascular outcomes in this group vs controls as well. The reasons why ROSE did not show improvement vs ACURASYS for the paralytic group may have been use of higher PEEP and lighter sedation targets in ROSE and fewer patients placed prone than in ACURASYS. In short, a lighter sedation strategy without paralytics using high PEEP and a standard low tidal volume strategy is as good as one with deeper sedation and paralytics and may result in fewer complications.

Source
Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome. N Engl J Med. 2019 May 23;380(21):1997-2008. doi: 10.1056/NEJMoa1901686. Epub 2019 May 19.

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Reviewed by Thomas Davis