1. 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 -

2. 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

3. 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 -

4. 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 -

5. 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 -

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

7. 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 -

8. 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 -

9. 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 -

10. 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 -

11. 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 -

12. Next steps Register for participation Get IRB approval (if needed)
Start inclusion