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RhabdomyolysisCyto-SOLVENCT04913298

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

A study testing Cytosorb therapy in people with Rhabdomyolysis and Acute Liver Injury, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rhabdomyolysis, Acute Liver Injury, Cytokine Storm
What is being tested?
Cytosorb therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteGermany
Study dates
1 Mar 2021to 15 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • other reasons for Cytosorb application

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • LMU munich

    Munich, Bavaria, 81377

Other trials in Germany

About this study

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

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.

Being tested
Cytosorb therapy
Keywords
Cytosorb, adsorption kinetics, saturation, critically ill patients
Medical subject headings
Rhabdomyolysis, Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cytosorb therapyDevice

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

Study groups in NCT04913298
Study groupRoleWhat they receive
Cytosorb therapyOtherblood samples are taken before and after the cytokine adsorber at given times
Receives: Device: Cytosorb therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 hours

  2. 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.

    Measured: 12 hours

  3. 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.

    Measured: 12 hours

Secondary outcomes (4)

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

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

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

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2021
  2. Study start1 Mar 2021
  3. Primary completion30 Apr 2023
  4. Study completion15 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04913298
Sponsor's protocol ID
21-0236
Acronym
Cyto-SOLVE
Status last verified
Feb 2024
First submitted
7 May 2021
Last updated
22 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39154299

  • 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.

    PubMed 38907120

  • 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.

    PubMed 37943350

Questions about this trial

What is this clinical trial studying?

A study testing Cytosorb therapy in people with Rhabdomyolysis and Acute Liver Injury, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04913298, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.

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