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

Cytokine Storm Clinical Trial

— Cyto-SOLVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04913298
• Other study ID #: 21-0236
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2024
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 15, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Liver Injury
• Cytokine Release Syndrome
• Cytokine Storm
• Rhabdomyolysis

Intervention

Device:
• Cytosorb therapy
Start of Cytosorb therapy is at the discretion of the attending physician

Locations

Country	Name	City	State
Germany	LMU munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change (percentage) in norepinephrine demand before and after the use of CytoSorb®		2 years
Secondary	Change ( percentage ) of liver toxic substances (e.g. bile acids) in patients´ blood due to the use of CytoSorb®		2 years
Secondary	Change ( percentage ) of myoglobin in patients´ blood due to the use of CytoSorb®		2 years
Secondary	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