NCT04913298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

May 7, 2021

Last Update Submit

February 21, 2024

Conditions

RhabdomyolysisAcute Liver InjuryCytokine Storm

Keywords

Cytosorbadsorption kineticssaturationcritically ill patients

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • 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

Study Arms (1)

Cytosorb therapy

OTHER

blood samples are taken before and after the cytokine adsorber at given times

Device: Cytosorb therapy

Interventions

Cytosorb therapyDEVICE

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

Cytosorb therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • intensive care therapy
  • hyperinflammation or acute liver dysfunction or rhabdomyolysis
  • need of continuous renal replacement therapy
  • treatment with Cytosorb (decision of the attending physician)

You may not qualify if:

  • \- other reasons for Cytosorb application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LMU munich

Munich, Bavaria, 81377, Germany

Location

Related Publications (3)

  • Graf H, Grafe C, Bruegel M, Happich FL, Wustrow V, Wegener A, Wilfert W, Zoller M, Liebchen U, Paal M, Scharf C. Extracorporeal Elimination of Pro- and Anti-inflammatory Modulators by the Cytokine Adsorber CytoSorb(R) in Patients with Hyperinflammation: A Prospective Study. Infect Dis Ther. 2024 Sep;13(9):2089-2101. doi: 10.1007/s40121-024-01028-8. Epub 2024 Aug 18.

    PMID: 39154299DERIVED

  • Graf H, Grafe C, Bruegel M, Zoller M, Maciuga N, Frank S, Weidhase L, Paal M, Scharf C. Myoglobin adsorption and saturation kinetics of the cytokine adsorber Cytosorb(R) in patients with severe rhabdomyolysis: a prospective trial. Ann Intensive Care. 2024 Jun 22;14(1):96. doi: 10.1186/s13613-024-01334-x.

    PMID: 38907120DERIVED

  • Greimel A, Habler K, Grafe C, Maciuga N, Brozat CI, Vogeser M, Zoller M, Happich FL, Liebchen U, Frank S, Paal M, Scharf C. Extracorporeal adsorption of protective and toxic bile acids and bilirubin in patients with cholestatic liver dysfunction: a prospective study. Ann Intensive Care. 2023 Nov 9;13(1):110. doi: 10.1186/s13613-023-01198-7.

    PMID: 37943350DERIVED

MeSH Terms

Conditions

RhabdomyolysisCytokine Release Syndrome

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 7, 2021

First Posted

June 4, 2021

Study Start

March 1, 2021

Primary Completion

April 30, 2023

Study Completion

December 15, 2023

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)