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vv-ECMO only (no cytokine adsorption)Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug3047 vv-ECMO + cytokine adsorption (Cytosorb adsorber) Wiki 1.00
drug2236 Serological test for COVID-19. Wiki 0.71
drug1612 No Intervention Wiki 0.41

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.08
D045169 Severe Acute Respiratory Syndrome NIH 0.07
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.08

There are 2 clinical trials

Clinical Trials


1 Cytokine Adsorption in Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation

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. Our primary goal is to investigate the efficacy of treatment with a CytoSorb® adsorber in patients with severe COVID-19 disease requiring venous ECMO over 72 hours after initiation of ECMO. The primary endpoint is the reduction of plasma interleukin-6 levels 72 hours after initiation of ECMO support. As secondary endpoints we investigate 30-day survival, vasopressor and volume requirements, lactate in terms of lactate and platelet function. As safety variables, we further investigate the levels of the applied antibiotics (usually ampicillin and sulbactam).

NCT04324528 Coronavirus COVID-19 SARS-CoV Infection Respiratory Failure Cytokine Storm Device: vv-ECMO + cytokine adsorption (Cytosorb adsorber) Device: vv-ECMO only (no cytokine adsorption)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption)

Measure: interleukin-6 (IL-6) level after 72 hours

Time: 72 hours

Secondary Outcomes

Description: survival after 30 days

Measure: 30-day-survival

Time: 72 hours

Description: needed dosage of norepinephrine and other vasopressors

Measure: vasopressor dosage

Time: 72 hours

Description: fluid balance levels during cytokine adsorption

Measure: fluid balance

Time: 72 hours

Description: serum-lactate levels during cytokine adsorption

Measure: lactate

Time: 72 hours

2 Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation - Randomized, Controlled, Open-label Intervention, Multi-center Trial (CYCOV-II-study)

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.

NCT04385771 Coronavirus Infection COVID SARS-CoV 2 Respiratory Failure Cytokine Storm Extracorporeal Membrane Oxygenation Device: vv-ECMO + cytokine adsorption (Cytosorb adsorber) Device: vv-ECMO only (no cytokine adsorption)
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Respiratory Insufficiency
HPO:Pneumonia

Primary Outcomes

Description: measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption)

Measure: IL-6 reduction by 75% or more after 72 hours as compared to the baseline measurement

Time: 72 hours

Description: time to successful ECMO-explantation within 30 days after randomization

Measure: time to successful ECMO-explantation

Time: 30 days

Secondary Outcomes

Description: 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

Measure: Ventilator free days (VFD)

Time: 30 days

Description: 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.

Measure: Time to extubation from ventilation and explantation from ECMO

Time: 30 days

Description: Overall survival time, defined as time from randomization to death. The time will be censored at the time of last visit for surviving patients.

Measure: Overall survival time

Time: 30 days

Description: Days on intensive care unit (ICU)

Measure: Days on intensive care unit (ICU)

Time: 30 days

Description: Vasopressor dosage of adrenaline, noradrenaline, vasopressin, and dobutamine at 24, 48,72 h

Measure: Vasopressor dosage

Time: 24, 48, 72 hours

Description: Total fluid[ml] substitution and fluid balance [ml] at 24, 48, 72 h

Measure: Fluid substitution and fluid balance

Time: 24, 48, 72 hours

Description: Serum lactate at 24, 48, 72 h

Measure: Serum lactate

Time: 24, 48, 72 hours

Description: Urine output at 24, 48, 72 h

Measure: Urine output

Time: 24, 48, 72 hours

Description: Willebrand factor at 24, 48, 72 h

Measure: Willebrand factor

Time: 24, 48, 72 hours

Description: d-dimers at 24, 48, 72 h

Measure: d-dimers

Time: 24, 48, 72 hours

Description: interleukin-6 levels at 24, 48, 72 h

Measure: interleukin-6 levels

Time: 24, 48, 72 hours

Description: Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the higher values explain higher disease severity)

Measure: SOFA-Score

Time: 24, 48, 72 hours

Description: serious complications or malfunctions related to the CytoSorb device

Measure: serious adverse device effects

Time: 30 days

Description: unintended air in the ECMO system during operation of the device

Measure: adverse event of special interest: air in the ECMO system

Time: 30 days

Description: unintended blood-clotting in the ECMO system during operation of the device

Measure: adverse event of special interest: blood-clotting in the ECMO system

Time: 30 days

Description: major bleeding events

Measure: adverse event of special interest: bleeding complications

Time: 30 days


Related HPO nodes (Using clinical trials)