Skip to main content
OpenTrials
Completed

NCT Number: NCT06503289

Myoglobin Removal With CytoSorb in Rhabdomyolysis

The aim of this observational study is to assess whether myoglobin removal with CytoSorb® ameliorates endothelial damage in severe rhabdomyolysis patients who are admitted to the intensive care unit. The primary objective of the study is:

- Does myoglobin removal with CytoSorb® reduces glycocalyx degradation markers?

Patients with severe rhabdomyolysis will receive the intervention and blood samples will be obtained in regular intervals.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sisli etfal research and training hospital

Istanbul, 34371, Turkey (Türkiye)

About this study

Rhabdomyolysis is characterized by destruction of muscle by various causes and is diagnosed by increased creatine kinase concentrations in the blood. Myoglobin released into the blood may cause acute kidney injury in up to half of these patients. The mortality caused by severe rhabdomyolysis is also high (32%). Extracorporeal modalities, such as CytoSorb (CS) can effectively eliminate the myoglobin from the bloodstream.

In addition to ischemic and inflammatory damage, myoglobin also causes direct endothelial cell injury. Degradation of the endothelial glycocalyx layer can be assessed by several biomarkers such as Syndecan-1, Heparan sulfate, cadherin

However, it is not fully known whether myoglobin elimination improves the outcomes or it is irrelevant of the outcome.

The investigator hypothesized that myoglobin elimination with CS alleviates the damage inflicted upon the endothelium and may have a role in improving patient outcomes in severe rhabdomyolysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Creatine Kinase > 5000 IU/L.
  • Myoglobin results can be obtained only after 5 working days after sampling in our center, therefore it cannot be used as an inclusion criteria.
  • GFR below 40 ml/min.

Exclusion criteria

  • High dose vasopressor requirement
  • Not expected to survive > 24 h
  • Lack of consent to participate

Treatment and study plan

Cytosorb therapy

Device

Extracorporeal treatment with cytosorb filter to patients diagnosed with rhabdomyolysis

Primary outcomes

  1. Syndecan-1

    Time frame: 12 hour

    Reduction in Syndecan-1 with CS therapy

Secondary outcomes

  1. glycocalyx markers

    Time frame: 12 hour

    Sustained reduction in other glycocalyx markers after CS therapy

  2. myoglobin

    Time frame: 12 hours

    Reduction in myoglobin levels with CS therapy

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

Effects of The Removal of Myoglobin With CytoSorb on The Endothelium and Glycocalyx Shedding Biomarkers in Patients With Rhabdomyolysis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2024
Registry last updated
Jun 15, 2025

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.

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