The prognosis of patients with severe COVID-19 disease, whose lungs are so severely diseased that they need to be supported by veno-venous ECMO (extracorporeal membrane oxygenation), is difficult to assess so far. Previously published data from studies, case reports and case series describe a very high mortality in this patient collective. The significance of established clinical prognostic cores in this patient population has not been systematically investigated. This is aggravated by the fact that even at very specialized centers only very few patients from this collective are (can be) treated, so that valid investigations are only possible in a multicenter patient collective. In this registry study, all patients diagnosed with COVID-19 and treated with vv-ECMO in the centers participating in the study should be retrospectively examined. The primary aim of the study is to investigate 30-day survival, secondary objectives include the analysis of different clinical scores at the time of ECMO implantation.
In December 2019, a series of unexplained cases of pneumonia in the city of Wuhan in China
has come to light. In virologic analyses of samples from the patients' deep respiratory
tract, a novel coronavirus was isolated (first named 2019-nCoV, then SARS-CoV-2). The disease
spread rapidly in the city of Wuhan in early 2020 and soon beyond. On 30 January 2020, the
Director-General of the World Health Organization (WHO) declared the outbreak a public health
emergency of international concern, and on 11 March 2020, the World Health Organization
declared the virus a pandemic.
In humans, an infection with the virus can cause respiratory tract infections or even very
severe pneumonia - these often end fatally, especially in old and pre-diseased patients. Due
to the novelty of the virus, the data basis for therapy is very limited. To date, there are
no clinical data for an effective specific therapy, nor is there a vaccination against the
virus available, so that therapy, especially intensive care treatment for very severe
courses, must concentrate only on supportive treatment of lung failure and other
complications.
The virus is highly contagious and infection results in a relevant number of deaths. Due to
very uncertain data on the spread of the virus in the population, it is difficult to estimate
the mortality rate - the case fatality rate is about 4% based on the known case numbers.
In reports on the treatment of the first cases in Wuhan (Hubei Province, China) in January
2020, the need for intensive care treatment is described for about a quarter of the inpatient
cases, 10-17% had to be ventilated invasively, and veno-venous extracorporeal membrane
oxygenation (vv-ECMO) was necessary in 2-4% of the inpatient cases. Patients requiring ECMO
have a high mortality rate in the studies published, so far. Recommendations for initiation
of ECMO in COVID-19 are being developed, though under continuous review.
Currently, little is known to guide clinicians in the choice of patients eligible for ECMO in
COVID-19, nor about the best time point for initiation of ECMO or the value of established
clinical scores for the prediction of the outcome of patients.
The aim of the study is to investigate survival in COVID-19 patients requiring vv-ECMO
support. Furthermore, the accuracy of clinical scores, established in intensive care medicine
for the prediction of outcome in severely ill patients will be assessed. Finally, time to
extubation from ventilation and time to ECMO-explantation will be evaluated. The study design
is a single-arm retrospective multi-center registry; therefore, no comparator will be
evaluated.
Device: vv-ECMO
vv-ECMO required in severe COVID-19 ARDS
Inclusion Criteria:
- patient admitted to ICU
- initiation of vv-ECMO
- definite SARS-CoV-2-infection
Exclusion Criteria:
- none
University Clinic Freiburg
Freiburg, Germany
Alexander Supady, MD, MPH, Principal Investigator
University Clinic Freiburg