Prospective Quality Assurance Study for the Application of Cytosorb® in Patients With Cytokine Storm, Rhabdomyolysis and Acute Liver Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rhabdomyolysis
- Sponsor
- Ludwig-Maximilians - University of Munich
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Change (percentage) in myoglobin measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with rhabdomyolysis
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Michael Zoller MD
Principle Investigator
Ludwig-Maximilians - University of Munich
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
Outcomes
Primary Outcomes
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 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 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 Outcomes
- 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®(2 years)