Skip to main content
OpenTrials
Completed

NCT Number: NCT04913298

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rhabdomyolysis Acute Liver Injury Cytokine Release Syndrome Cytokine Storm Inflammation Muscular Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LMU munich

Munich, Bavaria, 81377, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytosorb therapy

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Change (percentage) in norepinephrine demand before and after the use of CytoSorb®

    Time frame: 2 years

  2. Change ( percentage ) of liver toxic substances (e.g. bile acids) in patients´ blood due to the use of CytoSorb®

    Time frame: 2 years

  3. Change ( percentage ) of myoglobin in patients´ blood due to the use of CytoSorb®

    Time frame: 2 years

  4. Difference (percentage) between predicted mortality and real mortality of patients treated with CytoSorb®

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Acronym: Cyto-SOLVE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 4, 2021
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.