ACURASYS Trial

NEJM

September 16, 2010

Neuromuscular Blockers in Early Acute Respiratory Distress Syndrome

What was the research question?

  • Does the early use of neuromuscular blockade in patients with moderate to severe adult respiratory distress syndrome improve mortality?


How did they do it?

  • Multicenter, double-blinded, randomized trial in 20 ICUs in France.

  • 340 patients with moderate to severe ARDS defined as PO2/FiO2 of <150 for less than 48 hours.

  • Patients were randomized to receive 48-hour continuous infusion of cisatracurium or placebo. All patients were treated as per the ARMA trial protocol.

  • Primary outcome was the 90-day in-hospital mortality rate

  • Secondary outcome included ICU-free days, ventilator-free days, in-hospital death at day 28, days free of organ dysfunction, and days not in the hospital at day 28.


What did they find?

  • 90-day mortality was significantly lower in the cisatracurium group after being adjusted for baseline PaO2:FIO2 and plateau pressure and the Simplified Acute Physiology II score, adjusted Hazard ratio 0.68 (95% C.I. 0.48-0.98), p=0.04.

  • Crude 90-day mortality was not significantly different between the two groups (31.6% vs. 40.7%, p=0.08).

  • There was no significant difference in incidence of ICU-acquired paresis at ICU discharge (35.7% vs 31.5, p=0.51).

  • Sub-group analysis revealed that 90-day mortality benefit is confined to the sub-group with PaO2:FiO2 <120 (30.8% vs 44.6%, p=0.04).


Any limitation?

  • The study expected a mortality of 50% but the actual mortality was around 40% which makes the power of the study much less than predicted.


What does it mean?

  • The study supports the early use of neuromuscular blockade in moderate to severe ARDS with improvement in 90-day mortality

ACURASYS Trial