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

NCT ID: NCT04913298

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-12-15

Brief Summary

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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

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Conditions

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Rhabdomyolysis Acute Liver Injury Cytokine Storm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cytosorb therapy

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

Group Type OTHER

Cytosorb therapy

Intervention Type DEVICE

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

Interventions

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Cytosorb therapy

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Michael Zoller MD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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LMU munich

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 39154299 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38907120 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37943350 (View on PubMed)

Other Identifiers

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21-0236

Identifier Type: -

Identifier Source: org_study_id

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