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).
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