Prospective Study for the Application of Cytosorb® in Critically Ill Patients (Cyto-SOLVE)
Primary Purpose
Rhabdomyolysis, Acute Liver Injury, Cytokine Storm
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cytosorb therapy
Sponsored by
About this trial
This is an interventional treatment trial for Rhabdomyolysis focused on measuring Cytosorb, adsorption kinetics, saturation, critically ill patients
Eligibility 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
Sites / Locations
- LMU munichRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cytosorb therapy
Arm Description
blood samples are taken before and after the cytokine adsorber at given times
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Change (percentage) in norepinephrine demand before and after the use of CytoSorb®
Change ( percentage ) of liver toxic substances (e.g. bile acids) in patients´ blood due to the use of CytoSorb®
Change ( percentage ) of myoglobin in patients´ blood due to the use of CytoSorb®
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.
Full Information
NCT ID
NCT04913298
First Posted
May 7, 2021
Last Updated
March 7, 2023
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT04913298
Brief Title
Prospective Study for the Application of Cytosorb® in Critically Ill Patients
Acronym
Cyto-SOLVE
Official Title
Prospective Quality Assurance Study for the Application of Cytosorb® in Patients With Cytokine Storm, Rhabdomyolysis and Acute Liver Failure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhabdomyolysis, Acute Liver Injury, Cytokine Storm
Keywords
Cytosorb, adsorption kinetics, saturation, critically ill patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cytosorb therapy
Arm Type
Other
Arm Description
blood samples are taken before and after the cytokine adsorber at given times
Intervention Type
Device
Intervention Name(s)
Cytosorb therapy
Intervention Description
Start of Cytosorb therapy is at the discretion of the attending physician
Primary Outcome Measure Information:
Title
Change (percentage) in different cytokines (measured as a cytokine panel) measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with hyperinflammation
Description
Measurement of a cytokine panel (20 different cytokines in one panel) before and after the filter at different times.
Time Frame
12 hours
Title
Change (percentage) in myoglobin measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with rhabdomyolysis
Description
Measurement of myoglobin before and after the filter at different times.
Time Frame
12 hours
Title
Change (percentage) in bile acids (measured as a panel) measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with acute liver failure
Description
Measurement of bile acids before and after the filter at different times.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Change (percentage) in norepinephrine demand before and after the use of CytoSorb®
Time Frame
2 years
Title
Change ( percentage ) of liver toxic substances (e.g. bile acids) in patients´ blood due to the use of CytoSorb®
Time Frame
2 years
Title
Change ( percentage ) of myoglobin in patients´ blood due to the use of CytoSorb®
Time Frame
2 years
Title
Difference (percentage) between predicted mortality and real mortality of patients treated with CytoSorb®
Description
Mortality can be predicted by intensive care scores. We will investigate the difference between actual and predicted mortality.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Scharf
Phone
+49-89-4400-44152
Email
christina.scharf@med.uni-muenchen.de
Facility Information:
Facility Name
LMU munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Scharf
Phone
+49-89-4400-44152
Email
christina.scharf@med.uni-muenchen.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prospective Study for the Application of Cytosorb® in Critically Ill Patients
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