EOLIA
Trial question
What is the role of ECMO in patients with severe ARDS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 249
249 patients (72 female, 177 male).
Inclusion criteria: patients with very severe ARDS, as indicated by one of three criteria - a ratio of partial pressure of arterial oxygen to the FiO2 < 50 mmHg for > 3 hours; a ratio of partial pressure of arterial oxygen to the FiO2 < 80 mmHg for > 6 hours; or an arterial blood pH < 7.25 with a partial pressure of arterial CO2 of at least 60 mmHg for > 6 hours.
Key exclusion criteria: age < 18 years; receipt of mechanical ventilation for ≥ 7 days; pregnancy; long-term chronic respiratory insufficiency treated with oxygen therapy or noninvasive ventilation; cardiac failure resulting in venoarterial ECMO; a history of heparin-induced thrombocytopenia; cancer with a life expectancy < 5 years; a moribund condition.
Interventions
N=124 ECMO (percutaneous venovenous cannulation within 2 hours of randomization).
N=125 control (continued conventional treatment).
Primary outcome
Death at 60 days
35%
46%
46.0 %
34.5 %
23.0 %
11.5 %
0.0 %
Extracorporeal membrane
oxygenation
Control
No significant
difference ↔
No significant difference in death at 60 days (35% vs. 46%; RR 0.76, 95% CI 0.55 to 1.04).
Secondary outcomes
Significant decrease in treatment failure at 60 days (35% vs. 58%; RR 0.62, 95% CI 0.47 to 0.82).
Borderline significant increase in days free of RRT (50 days vs. 32 days; AD 18 days, 95% CI 0 to 51).
Borderline significant increase in days free from mechanical ventilation (23 days vs. 3 days; AD 20 days, 95% CI -5 to 32).
Safety outcomes
No significant differences in hemorrhagic stroke, pneumothorax, ventilator-associated pneumonia, massive bleeding.
Significant differences in severe thrombocytopenia (27% vs. 16%), bleeding events leading to packed red-cell transfusion (46% vs. 28%), ischemic stroke (0% vs. 5%).
Conclusion
In patients with very severe ARDS, as indicated by one of three criteria - a ratio of partial pressure of arterial oxygen to the FiO2 < 50 mmHg for > 3 hours; a ratio of partial pressure of arterial oxygen to the FiO2 < 80 mmHg for > 6 hours; or an arterial blood pH < 7.25 with a partial pressure of arterial CO2 of at least 60 mmHg for > 6 hours, ECMO was not superior to control with respect to death at 60 days.
Reference
Alain Combes, David Hajage, Gilles Capellier et al. Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome. N Engl J Med. 2018 May 24;378(21):1965-1975.
Open reference URL