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 -
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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
[email protected]
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Mortality of cancer patients according to ARDS severity
• n = 1,004
• 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 -
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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 -
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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 -
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SCREENING
Intubated non-surgical ICU cancer patients
Inclusion criteria
- adult patients (at least 18 years of age) and
- malignant disease (active or diagnosed within 5 years) and
STUDY COHORT
- ICU status: “full code” or “ICU trial” and
- acute respiratory distress syndrome (Berlin definition; PaO2/FiO2 ≤ 300)
Basic documentation
Exclusion criteria:
- recent intracranial bleeding
- post-surgical admissionx
SEVERE ARDS?
Severe ARDS (Berlin definition; PaO2/FiO2 ≤ 100)
Extended documentation
- Murray Score at least 3.0 or
ECMO CRITERIA?
- uncompensated hypercapnia pH < 7.2
Propensity score-based approach
- all under the condition of prone positioning ≥ 6 h
Outcome of ARDS cancer patients fulfilling virtual ECMO inclusion criteria
- The ViVe ECMO Study -
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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 -
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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 -
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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 -
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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 -
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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 -
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Next steps
• Register for participation
• Get IRB approval (if needed)
• Start inclusion
[email protected]
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