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

Not Applicable

Completed

• Conditions: Acute Liver Injury; Rhabdomyolysis; Cytokine Storm
• Interventions: Device: Cytosorb therapy

• Registration Number: NCT04913298
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-04
• Primary Completion: 2023-04-30
• Study Completion: 2023-12-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cytosorb therapy	Cytosorb therapy	blood samples are taken before and after the cytokine adsorber at given times

Primary Outcome Measures

Name	Time	Method
Change (percentage) in myoglobin measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with rhabdomyolysis	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	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	12 hours	Measurement of bile acids before and after the filter at different times.

Secondary Outcome Measures

Name	Time	Method
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	Mortality can be predicted by intensive care scores. We will investigate the difference between actual and predicted mortality.

Trial Locations

Locations (1)

LMU munich; 🇩🇪 Munich, Bavaria, Germany