Respiratory Failure Clinical Trial
— CYCOV-IIOfficial title:
Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation - Randomized, Controlled, Open-label Intervention, Multi-center Trial (CYCOV-II-study)
Verified date | March 2021 |
Source | University Hospital Freiburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world. Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen. Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome. From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients. The aim of the study is to investigate the influence of extracorporeal cytokine adsorption on interleukin-6-levels and time to successful ECMO explantation under controlled conditions in patients with particularly severe COVID-19 disease requiring extracorporeal membrane oxygenation.
Status | Suspended |
Enrollment | 80 |
Est. completion date | October 31, 2021 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - SARS-CoV-2-infection with COVID-pneumonia - vv-ECMO therapy Exclusion Criteria: - known patient will against participation in the study or against the measures applied in the study - a decision (made prior to inclusion of the patient into this trial) to terminate the treatment within the next 24 hours |
Country | Name | City | State |
---|---|---|---|
Germany | University Clinic Freiburg | Freiburg | |
Germany | Klinikum Ibbenbueren | Ibbenbueren | |
Germany | Klinikum Ludwigsburg | Ludwigsburg |
Lead Sponsor | Collaborator |
---|---|
Dr. Alexander Supady | Klinikum Ibbenbüren, Klinikum Ludwigsburg, Ludwig-Maximilians - University of Munich, Martin-Luther-Universität Halle-Wittenberg, SLK-Kliniken Heilbronn, University Hospital, Saarland, University of Ulm |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IL-6 reduction by 75% or more after 72 hours as compared to the baseline measurement | measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption) | 72 hours | |
Primary | time to successful ECMO-explantation | time to successful ECMO-explantation within 30 days after randomization | 30 days | |
Secondary | Ventilator free days (VFD) | Ventilator free days (VFD) in the first 30 days after randomization, where invasive mechanical ventilation (IMV), non-invasive ventilation (NIV) and ECMO are defined as ventilator days. VFD=0, if the patient dies in the first 30 days after randomization | 30 days | |
Secondary | Time to extubation from ventilation and explantation from ECMO | Time to extubation from ventilation and explantation from ECMO. Death under ventilation and/or ECMO will be analyzed as a competing event. The time will be censored at the time of last visit for surviving patients under ventilation and/or ECMO. | 30 days | |
Secondary | Overall survival time | Overall survival time, defined as time from randomization to death. The time will be censored at the time of last visit for surviving patients. | 30 days | |
Secondary | Days on intensive care unit (ICU) | Days on intensive care unit (ICU) | 30 days | |
Secondary | Vasopressor dosage | Vasopressor dosage of adrenaline, noradrenaline, vasopressin, and dobutamine at 24, 48,72 h | 24, 48, 72 hours | |
Secondary | Fluid substitution and fluid balance | Total fluid[ml] substitution and fluid balance [ml] at 24, 48, 72 h | 24, 48, 72 hours | |
Secondary | Serum lactate | Serum lactate at 24, 48, 72 h | 24, 48, 72 hours | |
Secondary | Urine output | Urine output at 24, 48, 72 h | 24, 48, 72 hours | |
Secondary | Willebrand factor | Willebrand factor at 24, 48, 72 h | 24, 48, 72 hours | |
Secondary | d-dimers | d-dimers at 24, 48, 72 h | 24, 48, 72 hours | |
Secondary | interleukin-6 levels | interleukin-6 levels at 24, 48, 72 h | 24, 48, 72 hours | |
Secondary | SOFA-Score | Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the higher values explain higher disease severity) | 24, 48, 72 hours | |
Secondary | serious adverse device effects | serious complications or malfunctions related to the CytoSorb device | 30 days | |
Secondary | adverse event of special interest: air in the ECMO system | unintended air in the ECMO system during operation of the device | 30 days | |
Secondary | adverse event of special interest: blood-clotting in the ECMO system | unintended blood-clotting in the ECMO system during operation of the device | 30 days | |
Secondary | adverse event of special interest: bleeding complications | major bleeding events | 30 days |
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