Accepted in Critical Care Medicine September 18th 2016; Online publication date April 14th 2017 Outcome of ARDS cancer patients fulfilling virtual ECMO inclusion criteria - The ViVe ECMO Study -

Outcome of ARDS cancer patients fulfilling virtual inclusion criteria for veno-venous ECMO - The ViVe ECMO Study - Peter Schellongowski Department of Medicine I, ICU 13i2, Medical University of Vienna, Vienna, Austria peter.schellongowski@meduniwien.ac.at

Mortality of cancer patients according to ARDS severity mild/mod./severe ARDS: 25/42/33% Hosp. mortality: 59/63/69% Azoulay et al, Intensive Care Med 2014 Outcome of ARDS cancer patients fulfilling virtual ECMO inclusion criteria - The ViVe ECMO Study -

Open questions about cancer patients with severe ARDS EFRAIM Characteristics of heme/onco cancer? Aetiology of (severe) ARDS? Risk factors for developing and surviving severe ARDS? Proportion, characteristics, risk factors + outcomes of potential ECMO patients Risks and benefits of ECMO in these patients ? ViVe ECMO Outcome of ARDS cancer patients fulfilling virtual ECMO inclusion criteria - The ViVe ECMO Study -

Proposal for project Observational multinational study on cancer patients with severe ARDS Aims: To better characterise cancer patients with severe ARDS To assess the proportion and outcomes of potential ECMO candidates To assess the impact of ECMO employing propensity score based matching Primary outcome 90 day mortality Outcome of ARDS cancer patients fulfilling virtual ECMO inclusion criteria - The ViVe ECMO Study -

Outcome of ARDS cancer patients fulfilling virtual ECMO inclusion criteria - The ViVe ECMO Study -

Virtual ECMO inclusion criteria Composite criteria satisfying CESAR, ELSO 2013 and EOLIA Outcome of ARDS cancer patients fulfilling virtual ECMO inclusion criteria - The ViVe ECMO Study -

Statistical considerations Inclusion: 600 patients with ARDS Expected: 200 patients with severe ARDS ECMO rate: If around 10% → propensity score feasible Outcome of ARDS cancer patients fulfilling virtual ECMO inclusion criteria - The ViVe ECMO Study -

Data to be collected ARDS COHORT: BASIC DOCUMENTATION - Cancer characteristics, ARF aetiology, goals of care, SOFA, outcome SEVERE ARDS: EXTENDED DOCUMENTATION for 7 days - Ventilator settings / Murray score, ABGs - Supportive ARDS therapies, fluid management, other ICU measures - ARF aetiology - SOFA score on day 3/5/7 - Complications including bleeding events, transfusions ECMO: ECMO THERAPY SPECIFIC DATA Outcome of ARDS cancer patients fulfilling virtual ECMO inclusion criteria - The ViVe ECMO Study -

Practical aspects Amount of data to be collected max. ½ of EFRAIM Paper based case report form Data management/statistics: Laboratoire Biostatistique et épidémiologie clinique INSERM, Paris Diderot IRB approval obtained at the Medical University of Vienna Outcome of ARDS cancer patients fulfilling virtual ECMO inclusion criteria - The ViVe ECMO Study -

Requirements for study participation No general reluctance to prone ARDS patients Inclusion of ≥ 10 ARDS cancer patients in one year Not required: ability to perform ECMO Outcome of ARDS cancer patients fulfilling virtual ECMO inclusion criteria - The ViVe ECMO Study -

Next steps Register for participation Get IRB approval (if needed) Start inclusion peter.schellongowski@meduniwien.ac.at