| Design | Randomised trial, stopped for futility at the second interim analysis |
|---|---|
| Treatment | Early continuous cisatracurium infusion with deep sedation |
| Control | Usual care with lighter sedation targets |
| Population | 1006 patients enrolled a median of 7.6 hours after the onset of moderate-to-severe ARDS |
| Follow-up | 90 days |
| Primary endpoint | In-hospital death at 90 days |
| Result | No significant difference in 90-day mortality. In the intervention group 488 of 501 (97.4%) received cisatracurium for a median of 47.8 hours; 86 of 505 (17.0%) controls received a neuromuscular blocking agent. The trial was stopped for futility. |
| Secondary endpoints | Ventilator-free days, ICU-acquired weakness, days out of hospital |
Among patients with moderate-to-severe ARDS who were treated with a strategy involving a high PEEP, there was no significant difference in mortality at 90 days between patients who received an early and continuous cisatracurium infusion and those who were treated with a usual-care approach with lighter sedation targets.
The trial authors, in the published abstract
The important difference from ACURASYS is the control arm: ROSE compared paralysis against light sedation rather than against deep sedation without paralysis. Read together, the pair suggest the earlier benefit may have been avoidance of deep sedation rather than the paralysis itself.
Moss M, Huang DT, Brower RG, et al. Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome. N Engl J Med 2019 May 23;380(21):1997-2008.