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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04913298
Acronym
Cyto-SOLVE
Enrollment
57
Registered
2021-06-04
Start date
2021-03-01
Completion date
2023-12-15
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Liver Injury, Cytokine Storm, Rhabdomyolysis

Keywords

Cytosorb, adsorption kinetics, saturation, critically ill patients

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.

Interventions

Start of Cytosorb therapy is at the discretion of the attending physician

Sponsors

Ludwig-Maximilians - University of Munich
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change (percentage) in different cytokines (measured as a cytokine panel) measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with hyperinflammation12 hoursMeasurement 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 rhabdomyolysis12 hoursMeasurement 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 failure12 hoursMeasurement of bile acids before and after the filter at different times.

Secondary

MeasureTime frameDescription
Change (percentage) in norepinephrine demand before and after the use of CytoSorb®2 years
Difference (percentage) between predicted mortality and real mortality of patients treated with CytoSorb®2 yearsMortality can be predicted by intensive care scores. We will investigate the difference between actual and predicted mortality.
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026