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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
Sponsor:
Information provided by (Responsible Party):
Michael Zoller MD, Ludwig-Maximilians - University of Munich

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rhabdomyolysis Acute Liver Injury Cytokine Storm Device: Cytosorb therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cytosorb therapy
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Change (percentage) in norepinephrine demand before and after the use of CytoSorb® [ Time Frame: 2 years ]
  2. Change ( percentage ) of liver toxic substances (e.g. bile acids) in patients´ blood due to the use of CytoSorb® [ Time Frame: 2 years ]
  3. Change ( percentage ) of myoglobin in patients´ blood due to the use of CytoSorb® [ Time Frame: 2 years ]
  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

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


Contacts
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Contact: Christina Scharf +49-89-4400-44152 christina.scharf@med.uni-muenchen.de

Locations
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Germany
LMU munich Recruiting
Munich, Bavaria, Germany, 81377
Contact: Christina Scharf    +49-89-4400-44152    christina.scharf@med.uni-muenchen.de   
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
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Responsible Party: Michael Zoller MD, Principle Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT04913298    
Other Study ID Numbers: 21-0236
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michael Zoller MD, Ludwig-Maximilians - University of Munich:
Cytosorb
adsorption kinetics
saturation
critically ill patients
Additional relevant MeSH terms:
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Rhabdomyolysis
Cytokine Release Syndrome
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Muscular Diseases
Musculoskeletal Diseases