Clinical Scores for Outcome Prediction in Patients With Severe COVID-19 Pneumonia Requiring ECMO
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|ClinicalTrials.gov Identifier: NCT04405973|
Recruitment Status : Completed
First Posted : May 28, 2020
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment|
|COVID-19 SARS-CoV 2 Extracorporeal Membrane Oxygenation ARDS||Device: vv-ECMO|
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.
|Study Type :||Observational|
|Actual Enrollment :||133 participants|
|Official Title:||Clinical Scores for Outcome Prediction in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation - a Retrospective Multi-center Registry Study|
|Actual Study Start Date :||May 19, 2020|
|Actual Primary Completion Date :||September 30, 2020|
|Actual Study Completion Date :||September 30, 2020|
COVID-19 ARDS, vv-ECMO
All patients in the study centers with diagnosed COVID-19 infection (PCR proven) and treatment with vv-ECMO
vv-ECMO required in severe COVID-19 ARDS
- overall survival [ Time Frame: 30 days ]time from ECMO-implantation to death
- duration of ECMO treatment [ Time Frame: 30 days ]time from ECMO-implantation to ECMO-explantation
- duration of ventilation treatment [ Time Frame: 30 days ]time from ECMO-implantation to extubation
- duration of initiation of ECMO treatment to ICU discharge [ Time Frame: 30 days ]time from ECMO-implantation to ICU-discharge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405973
|University Clinic Freiburg|
|Freiburg, Germany, 79106|
|Principal Investigator:||Alexander Supady, MD, MPH||University Clinic Freiburg|