6/29/23, 1:13 AM ROSE Pathway Feedback Search Clinical Topics Home Studies ROSE ROSE Disease Acute respiratory distress syndr Trial question What is the role of early continuous neuromuscular blockade in patients with ARDS receiving mechanical ventilation? Study design Multi-center Open label RCT Population Characteristics of study participants 44.0% female N = 1006 56.0% male 1006 patients (446 female, 560 male) Inclusion criteria: patients with moderate-to-severe ARDS receiving high PEEP mechanical ventilation Key exclusion criteria: continuous neuromuscular blockade at enrollment; chronic respiratory failure; severe chronic liver disease; expected duration of mechanical ventilation < 48 hours Interventions N=501 intervention (48-hour continuous neuromuscular blockade with cisatracurium and concomitant deep sedation) N=505 control (usual care with lighter sedation targets) https://web.pathway.md/studies/reckxGj47qZC4n8jm 1/2 6/29/23, 1:13 AM ROSE Pathway Primary outcome In-hospital death from any cause at 90 days 42.8 % 42.8 42.5 32.1 % 21.4 % 10.7 % No significant difference 0.0 % Intervention Control No significant difference in in-hospital death from any cause at 90 days (42.5% vs. 42.8%; ARD -0.3, 95% CI -6.4 to 5.9) Secondary outcomes No significant difference in the rate of in-hospital death by 28 days (36.7% vs. 37%; ARD -0.3, 95% CI -6.3 to 5.7) No significant difference in days free of ventilation at day 28 (9.6 days vs. 9.9 days; AD -0.3 days, 95% CI -1.7 to 1) No significant difference in days not in hospital at day 28 (5.7 days vs. 5.9 days; AD -0.2 days, 95% CI -1.1 to 0.8) Safety outcomes No significant differences in in-hospital recall of paralysis, ICU acquired weakness, serious adverse events. Significant difference in serious cardiovascular events (2.8% vs. 0.8%). Conclusion In patients with moderate-to-severe ARDS receiving high PEEP mechanical ventilation, intervention was not superior to control with respect to a in-hospital death from any cause at 90 days. Reference National Heart, Lung, and Blood Institute PETAL Clinical Trials Network et al. Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome. N Engl J Med. 2019 May 23;380(21):1997- 2008. Open reference URL https://web.pathway.md/studies/reckxGj47qZC4n8jm 2/2