Jonathan Sevransky, MD
In patients with early, severe acute respiratory distress syndrome (ARDS), does short-term treatment with cisatracurium besylate, a neuromuscular-blocking agent, improve clinical outcomes?
Randomized placebo-controlled trial (ARDS et Curarisation Systematique [ACURASYS] study). ClinicalTrials.gov NCT00299650.
Blinded (patients, clinicians, outcome assessors, monitors, and data analysts).*
20 intensive care units (ICUs) in France.
340 patients (mean age 58 y) who were receiving endotracheal mechanical ventilation for acute hypoxemic respiratory failure and had all of the following for ≤ 48 hours: PaO2/FIO2 < 150 with ventilator set to a positive end-expiratory pressure ≥ 5 cm H20 and tidal volume of 6 to 8 mL/kg predicted body weight; bilateral pulmonary infiltrates consistent with edema; and no clinical evidence of left atrial hypertension. Exclusion criteria included pregnancy, increased intracranial pressure, severe chronic respiratory disease (chronic oxygen use or home ventilation), and severe chronic liver disease.
Intravenous cisatracurium besylate (n = 178) or placebo (n = 162). After the Ramsay sedation score reached 6 (no response to glabellar tap) and ventilator settings were adjusted, a rapid infusion of 15 mg was administered, followed by a continuous infusion of 37.5 mg/h for 48 hours.
Primary outcome was 90-day mortality (before discharge and within 90 d after enrollment). Secondary outcomes included ventilator-free days, days without organ failure (cardiovascular, renal, hepatic, or coagulation abnormalities), barotrauma, and ICU-acquired paresis.
99.7% (intention-to-treat analysis).
Patients who received cisatracurium had a lower adjusted risk for mortality at 90 days and lower risk for barotrauma (mostly pneumothorax) than those who received placebo (Table). The groups had a similar risk for ICU-acquired paresis at 28 days and ICU discharge; however, < 60% of patients were included in these analyses (29% [28/96] vs 32% [25/77], P = 0.64, and 36% [40/112] vs 31% [28/89], P = 0.51, respectively). At 28 days, the cisatracurium group had more ventilator-free days (mean 10.6 vs 8.5, P = 0.04) and days without organ failure (mean 15.8 vs 12.2, P = 0.01).
In patients with early, severe acute respiratory distress syndrome, short-term cisatracurium treatment reduced mortality at 90 days.
Cisatracurium vs placebo in patients with early, severe acute respiratory distress syndrome†
*Abbreviations defined in Glossary. RRR, NNT, and CI calculated from data in article.
‡Calculated from hazard ratio in article (adjusted for baseline PaO2/FIO2, Simplified Acute Physiology Score II, and plateau pressure).
§New pneumothorax, pneumomediastinum, subcutaneous emphysema, or pneumatocele > 2 cm in diameter.
Jonathan Sevransky. 48 hours of cisatracurium reduced 90-day mortality in patients with early, severe ARDS. Ann Intern Med. 2011;154:JC1–3. doi: 10.7326/0003-4819-154-2-201101180-02003
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Published: Ann Intern Med. 2011;154(2):JC1-3.
Acute Respiratory Distress Syndrome/Acute Lung Injury, Pulmonary/Critical Care.
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