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The EOLIA Trial

Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome

Designed to answer key question regarding the efficacy of vv-ECMO in severe ARDS by determining the effect of:

  • Early initiation of ECMO in most severe forms of ARDS
  • Compared to conventional management
Download the summary of the EOLIA trial

Extracorporeal membrane oxygenation
for severe acute respiratory distress syndrome
The EOLIA Trial

The efficacy of venovenous extracorporeal membrane oxygenation (ECMO) in patients with severe acute respiratory distress syndrome (ARDS) remains controversial. [13] EOLIA trial was designed to determine the effect of early initiation of ECMO in patients with the most severe forms of ARDS.[1]

ECLS (ECMO) therapy in ICU for adult patients with ARDS

Early ECMO

 
35% mortality
(44/124)
ECLS (ECMO) therapy in ICU for adult patients with ARDS

249 Patients

 
124 received immediate vv-ECMO and
125 continued conventional treatment
ECLS (ECMO) therapy in ICU for adult patients with ARDS

Conventional Ventilation*

 
46% mortality
(57/125)

*with ECMO as rescue if needed

Why did we need the EOLIA Trial?

  • There have been recent advances in ECMO technology
  • Encouraging results of ECMO
    - Influenza A (H1N1) associated ARDS
    - CESAR randomized trial, UK  
  • Efficacy of vv-ECMO in severe ARDS remains controversial
  • EOLIA trial designed to determine the effect of
    - Early initiation of ECMO in patients with the most severe forms of ARDS

The EOLIA Trial
Results[1]

EOLIA Trial results: 11% difference in mortality at 60 days

Mortality at 60 days

  • ECMO group - 44 of 124 patients (35%)
  • Control group - 57 of 125 (46%)
  • 11% reduction in mortality in the ECMO group compared to the conventional group[2]
    (relative risk, 0.76; 95% confidence interval [CI], 0.55 to 1.04;P = 0.09)
EOLIA Trial results: The failure (mortality rate) in the ECMO group was 35% vs 57% in the conventional group.

Key secondary endpoint

  • Death in the ECMO group and treatment failure (death and crossover) in the control group.
  • Rescue ECMO occurred in 35/125 patients (28%) in the control group due to refractory hypoxemia with mortality of 57% in the rescue group.
  • Treatment failure occurred in 57% of the control group.
EOLIA Trial results: Number of days free from failure from Inclusion to Day 60

Days free from failure

There is a strong signal demonstrating more days free from respiratory failure, renal failure, organ failure, neurological failure and cardiac failure in the ECMO group compared to the control group.

EOLIA Trial results: ECMO Arm Complications

ECMO Complications

  • Complication rates were low showing ECMO to be a safe and effective therapy option.
  • The stroke rate was higher in the conventional group than in the ECMO group.

Key Takeaways

  • In an editorial written for the New England Journal of Medicine, Dr. Jeffrey Drazen made the statement that the mortality as well as the secondary endpoints all point to the conclusion that ECMO probably has some benefit despite the trial not being traditionally positive.[3]  
  • The study was stopped by the Data Safety Monitoring Board due to the belief it would not reach the primary endpoint.  This has been the subject of much discussion.
  • Rescue ECMO is an effective treatment but has a higher mortality rate.
  • Ventilation strategies and proning are key components to the treatment of patients presenting with ARDS.
Read the full article here
EOLIA Trial results: Probability of Surviving without treatment failure

EOLIA challenges

  • The authors found the 11% absolute mortality reduction “remarkable”
  • The trial was planned with the assumption that there would be a 20% reduction in mortality which essentially means there was a 20% risk of mortality in the protective mechanical ventilation group vs zero in the ECMO group.
  • Negative trials do not indicate whether a given intervention is useless, but simply fail to confirm the hypothesis.
  • The authors asked the question if there is really much of a difference between a  p value of 0.07 is so different from that of the magic 0.05?

1) Please also note the article “Use of ECMO in ARDS: does the EOLIA trial really help?”  by Luciano Gattinoni, Francesco Vasques, and Michael Quintel Crit Care. 2018; 22: 171.
Published online 2018 Jul 5. doi:  10.1186/s13054-018-2098-6

Download the summary of the EOLIA trial

Understand the challenges of EOLIA

Understanding the Challenges of EOLIA

The presentation "Understanding the Challenges of EOLIA" summarizes the study explaining trial procedures, criteria and results.

Understand the challenges of EOLIA

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Alle referanser

  1. Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome

  2. Use of ECMO in ARDS: does the EOLIA trial really help? – Commentary in Critical Care

  3. Learning from a Trial Stopped by a Data and Safety Monitoring Board – editorial
    David Harrington, Ph.D., and Jeffrey M. Drazen, M.D. N Engl J Med 2018; 378:2031-2032

  4. EuroELSO webinar – The EOLIA Trial

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