Prospective Study for the Application of Cytosorb® in Critically Ill Patients (Cyto-SOLVE)
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|ClinicalTrials.gov Identifier: NCT04913298|
Recruitment Status : Recruiting
First Posted : June 4, 2021
Last Update Posted : June 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Rhabdomyolysis Acute Liver Injury Cytokine Storm||Device: Cytosorb therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Quality Assurance Study for the Application of Cytosorb® in Patients With Cytokine Storm, Rhabdomyolysis and Acute Liver Failure|
|Actual Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||December 30, 2023|
blood samples are taken before and after the cytokine adsorber at given times
Device: Cytosorb therapy
Start of Cytosorb therapy is at the discretion of the attending physician
- Change (percentage) in different cytokines (measured as a cytokine panel) measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with hyperinflammation [ Time Frame: 12 hours ]Measurement of a cytokine panel (20 different cytokines in one panel) before and after the filter at different times.
- Change (percentage) in myoglobin measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with rhabdomyolysis [ Time Frame: 12 hours ]Measurement of myoglobin before and after the filter at different times.
- Change (percentage) in bile acids (measured as a panel) measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with acute liver failure [ Time Frame: 12 hours ]Measurement of bile acids before and after the filter at different times.
- Change (percentage) in norepinephrine demand before and after the use of CytoSorb® [ Time Frame: 2 years ]
- Change ( percentage ) of liver toxic substances (e.g. bile acids) in patients´ blood due to the use of CytoSorb® [ Time Frame: 2 years ]
- Change ( percentage ) of myoglobin in patients´ blood due to the use of CytoSorb® [ Time Frame: 2 years ]
- Difference (percentage) between predicted mortality and real mortality of patients treated with CytoSorb® [ Time Frame: 2 years ]Mortality can be predicted by intensive care scores. We will investigate the difference between actual and predicted mortality.
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): NCT04913298
|Contact: Christina Scharfemail@example.com|
|Munich, Bavaria, Germany, 81377|
|Contact: Christina Scharf +49-89-4400-44152 firstname.lastname@example.org|