Prospective Study for the Application of Cytosorb® in Critically Ill Patients

Study Overview
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Brief Summary
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The mortality of critically ill patients is persistently high and requires targeted therapy of pathophysiological disorders. One approach to optimize therapy is the use of the cytokine adsorber Cytosorb®, which has a CE certification for the indications hyperinflammation, rhabdomyolysis and liver failure and is therefore frequently used in patients with sepsis, polytrauma and acute liver failure. Although few clinical data describe the efficiency mostly retrospectively, there are no data on real-time elimination performance and saturation kinetics during the course of treatment. These questions should be answered by the present study.

Official Title
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Prospective Quality Assurance Study for the Application of Cytosorb® in Patients With Cytokine Storm, Rhabdomyolysis and Acute Liver Failure

Conditions
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Rhabdomyolysis, Acute Liver Injury, Cytokine Storm

Intervention / Treatment
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* Device: Cytosorb therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: intensive care therapy hyperinflammation or acute liver dysfunction or rhabdomyolysis need of continuous renal replacement therapy treatment with Cytosorb (decision of the attending physician) Exclusion Criteria: - other reasons for Cytosorb application

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cytosorb therapy<br>blood samples are taken before and after the cytokine adsorber at given times | Device: Cytosorb therapy<br>* Start of Cytosorb therapy is at the discretion of the attending physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (percentage) in different cytokines (measured as a cytokine panel) measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with hyperinflammation | Measurement of a cytokine panel (20 different cytokines in one panel) before and after the filter at different times. | 12 hours | 
| Change (percentage) in myoglobin measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with rhabdomyolysis | Measurement of myoglobin before and after the filter at different times. | 12 hours | 
| Change (percentage) in bile acids (measured as a panel) measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with acute liver failure | Measurement of bile acids before and after the filter at different times. | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (percentage) in norepinephrine demand before and after the use of CytoSorb® |  | 2 years | 
| Change ( percentage ) of liver toxic substances (e.g. bile acids) in patients´ blood due to the use of CytoSorb® |  | 2 years | 
| Change ( percentage ) of myoglobin in patients´ blood due to the use of CytoSorb® |  | 2 years | 
| Difference (percentage) between predicted mortality and real mortality of patients treated with CytoSorb® | Mortality can be predicted by intensive care scores. We will investigate the difference between actual and predicted mortality. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytosorb, adsorption kinetics, saturation, critically ill patients