Myoglobin Removal With CytoSorb in Rhabdomyolysis

June 13, 2025 updated by: Olcay Dilken, Sisli Hamidiye Etfal Training and Research Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34371
        • Sisli etfal research and training hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

18 years and older patients who need cytosorb therapy due to rhadomyolysis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cytosorb therapy
18 years older patients who need cytsorb therapy due to rhabdomyolysis
Device: Cytosorb therapy
Extracorporeal treatment with cytosorb filter to patients diagnosed with rhabdomyolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Syndecan-1
Time Frame: 12 hour
Reduction in Syndecan-1 with CS therapy
12 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glycocalyx markers
Time Frame: 12 hour
Sustained reduction in other glycocalyx markers after CS therapy
12 hour
myoglobin
Time Frame: 12 hours
Reduction in myoglobin levels with CS therapy
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Investigators

  • Study Director: mustafa altınay, şişli etfal eğitim araştırma hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

January 22, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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