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A CLUE study (Covid 19 Flu ECMO) [COVID-19]

  • Research type

    Research Study

  • Full title

    A cohort study comparing the differences in baseline characteristics and outcomes in patients with influenza and COVID-19 ARDS treated with veno-venous extracorporeal membrane oxygenation (ECMO) and conventional therapy in a severe acute respiratory failure unit

  • IRAS ID

    285452

  • Contact name

    Stephane Ledot

  • Contact email

    s.ledot@rbht.nhs.uk

  • Clinicaltrials.gov Identifier

    n/a, n/a

  • Duration of Study in the UK

    1 years, 0 months, 2 days

  • Research summary

    A role for venous-venous extracorporeal membrane oxygenation (VV ECMO) in acute respiratory distress syndrome (ARDS) secondary to viral pneumonia which is refractory to maximal conventional therapy is well established. In the context of COVID-19 infection, however, the potential benefits of VV ECMO and the patients who are most likely to benefit remain unknown. While the majority of infections with COVID-19 lead to only a mild respiratory illness, a significant minority require hospital admission and an estimated 5% of cases require mechanical ventilation.In patients admitted to intensive care units (ICU), progressive respiratory failure secondary to ARDS has been identified as a primary cause of mortality. Clinical management of patients admitted to ICU suffering from COVID-19 is largely supportive but evidence in favour of supplementary therapies including lung protective ventilation, prone ventilation and neuromuscular blocking agents is quickly evolving.Given the unparalleled spread of COVID-19, and the predominance of respiratory failure in the pathogenesis of the most unwell patients, an extremely large cohort of potential candidates for VV ECMO treatment has rapidly developed. \n\nDespite uncertainty regarding the pathophysiology, natural history and optimal therapy for COVID-19 infection, interim guidance published by the WHO and NICE recommend considering VV ECMO in patients with severe, potentially reversible respiratory failure where conventional intensive care therapy has failed \n\nThe evidence base for the recommendation of ECMO treatment in the context of COVID-19 and the criteria for patient selection remains extremely limited. A handful of retrospective cohort studies have reported very poor short-term outcomes for patients treated with ECMO in China.The cumulative mortality of these studies is greater than 80%. The extent to which this experience translates into other ECMO centres outside China is uncertain. \nData on the clinical utility of ECMO and other advanced rescue therapies in ARDS, the differences between baseline characteristics, on ECMO experience, outcomes and longer term follow up, resource utilisation and patient selection is urgently needed.

  • REC name

    East Midlands - Derby Research Ethics Committee

  • REC reference

    20/EM/0204

  • Date of REC Opinion

    11 Aug 2020

  • REC opinion

    Favourable Opinion