Chapters
1, 4, 7
Comparator
Conventional management with ECMO permitted as rescue
ECMO type
VV
Intervention
Immediate VV ECMO
Limitations
Stopped for futility at 75% of planned enrolment. 35/125 (28%) of controls crossed over to rescue ECMO; 20/35 (57%) of those died.
N
249
Population
Very severe ARDS: PaO2/FiO2 <50 for >3 h, or <80 for >6 h, or pH <7.25 with PaCO2 >60 for >6 h
Primary endpoint
All-cause mortality at 60 days
Result
35% (44/124) vs 46% (57/125); RR 0.76 (95% CI 0.55-1.04), p=0.09
Verified
What it does NOT tell us
It does not compare ECMO with no ECMO. With 28% crossover the trial compares early ECMO against rescue ECMO, and therefore cannot exclude a clinically important benefit.
What it tells us
Early ECMO in very severe ARDS produced an 11 percentage point absolute mortality difference that did not reach conventional significance in an underpowered trial.
Year
2018