NCT04913298: Cyto-SOLVE

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

Completed NA Last updated 22 February 2024

What this trial tests

NA trial testing Cytosorb therapy in Rhabdomyolysis in 57 participants. Completed in 15 December 2023.

Timeline

1 March 2021

Primary endpoint
30 April 2023

15 December 2023

Quick facts

Lead sponsor	Ludwig-Maximilians - University of Munich
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	57
Start date	1 March 2021
Primary completion	30 April 2023
Estimated completion	15 December 2023
Sites	1 location across Germany

Drugs / interventions tested

• Cytosorb therapy

Conditions studied

• Rhabdomyolysis — all drugs for Rhabdomyolysis →
• Acute Liver Injury — all drugs for Acute Liver Injury →
• Cytokine Storm — all drugs for Cytokine Storm →

Sponsor

Ludwig-Maximilians - University of Munich

Who can join

18 and older, any sex, with Rhabdomyolysis or Acute Liver Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extracorporeal adsorption of protective and toxic bile acids and bilirubin in patients with cholestatic liver dysfunction: a prospective study.
   Greimel A, Habler K, Gräfe C, Maciuga N, et al · · 2023 · cited 16× · PMID 37943350 · DOI 10.1186/s13613-023-01198-7
2. Hemoadsorption therapy for myoglobin removal in rhabdomyolysis: consensus of the hemoadsorption in rhabdomyolysis task force.
   Forni L, Aucella F, Bottari G, Büttner S, et al · · 2024 · cited 15× · PMID 39085790 · DOI 10.1186/s12882-024-03679-8
3. Myoglobin adsorption and saturation kinetics of the cytokine adsorber Cytosorb® in patients with severe rhabdomyolysis: a prospective trial.
   Graf H, Gräfe C, Bruegel M, Zoller M, et al · · 2024 · cited 14× · PMID 38907120 · DOI 10.1186/s13613-024-01334-x
4. The effect of cytosorb® application on kidney recovery in critically ill patients with severe rhabdomyolysis: a propensity score matching analysis.
   Gräfe C, Liebchen U, Greimel A, Maciuga N, et al · · 2023 · cited 14× · PMID 37728069 · DOI 10.1080/0886022x.2023.2259231
5. The cytokine adsorber Cytosorb® does not reduce ammonia concentrations in critically ill patients with liver failure.
   Liebchen U, Paal M, Gräfe C, Zoller M, et al · · 2023 · cited 11× · PMID 36763124 · DOI 10.1007/s00134-023-06998-w
6. Extracorporeal Elimination of Pro- and Anti-inflammatory Modulators by the Cytokine Adsorber CytoSorb^® in Patients with Hyperinflammation: A Prospective Study.
   Graf H, Gräfe C, Bruegel M, Happich FL, et al · · 2024 · cited 8× · PMID 39154299 · DOI 10.1007/s40121-024-01028-8
7. Correlation of bilirubin and toxic bile acids in critically ill patients with cholestatic liver dysfunction and adsorber application.
   Gräfe C, Graf H, Wustrow V, Liebchen U, et al · · 2024 · cited 3× · PMID 39294181 · DOI 10.1038/s41598-024-72676-6
8. Angiopoietin-2 adsorption attempt with the cytokine adsorber cytosorb in critically ill patients.
   Graf H, Gräfe C, Paal M, Habler K, et al · · 2025 · PMID 41034327 · DOI 10.1038/s41598-025-21215-y