Acute Kidney InjuryNCT06503289
Myoglobin Removal With CytoSorb in Rhabdomyolysis
An observational study of Acute Kidney Injury and Rhabdomyolysis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury, Rhabdomyolysis, Endothelial Dysfunction
- What is being tested?
- Cytosorb therapy
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 May 2025
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 years and older patients who need cytosorb therapy due to rhadomyolysis
Who may be able to join
- 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.
Who cannot join
- High dose vasopressor requirement
- Not expected to survive > 24 h
- Lack of consent to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli etfal research and training hospital
Istanbul, 34371
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Kidney Injury, Rhabdomyolysis, Endothelial Dysfunction
- Being tested
- Cytosorb therapy
- Keywords
- Myoglobin, Rhabdomyolysis, Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury, Rhabdomyolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytosorb therapyDevice
Extracorporeal treatment with cytosorb filter to patients diagnosed with rhabdomyolysis
| Study group | Role | What they receive |
|---|---|---|
| cytosorb therapy | 18 years older patients who need cytsorb therapy due to rhabdomyolysis Receives: Device: Cytosorb therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Syndecan-1
Reduction in Syndecan-1 with CS therapy
Measured: 12 hour
Secondary outcomes (2)
glycocalyx markers
Sustained reduction in other glycocalyx markers after CS therapy
Measured: 12 hour
myoglobin
Reduction in myoglobin levels with CS therapy
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Aug 2024
- Primary completion22 Jan 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olcay Dilken, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- mustafa altınay, Study director, şişli etfal eğitim araştırma hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503289
- Sponsor's protocol ID
- 2346
- Status last verified
- Jun 2025
- First submitted
- 10 Jul 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albrecht F, Schunk S, Fuchs M, Volk T, Geisel J, Fliser D, Meiser A. Rapid and Effective Elimination of Myoglobin with CytoSorb(R) Hemoadsorber in Patients with Severe Rhabdomyolysis. Blood Purif. 2024;53(2):88-95. doi: 10.1159/000534479. Epub 2023 Nov 2.
PubMed 37918366D'Agnillo F, Alayash AI. A role for the myoglobin redox cycle in the induction of endothelial cell apoptosis. Free Radic Biol Med. 2002 Oct 15;33(8):1153-64. doi: 10.1016/s0891-5849(02)01007-9.
PubMed 12374627Hahn RG, Patel V, Dull RO. Human glycocalyx shedding: Systematic review and critical appraisal. Acta Anaesthesiol Scand. 2021 May;65(5):590-606. doi: 10.1111/aas.13797. Epub 2021 Mar 7.
PubMed 33595101
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of The Removal of Myoglobin With CytoSorb on The Endothelium and Glycocalyx Shedding Biomarkers in Patients With Rhabdomyolysis
- ClinicalTrials.gov ID
- NCT06503289
- Acronym / sponsor ID
- 2346
- Conditions
- Acute Kidney Injury, Rhabdomyolysis, Endothelial Dysfunction
- Keywords
- Myoglobin, Rhabdomyolysis, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cytosorb therapy | – | Device: Cytosorb therapy18 years older patients who need cytsorb therapy due to rhabdomyolysis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years and older patients who need cytosorb therapy due to rhadomyolysis
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- High dose vasopressor requirement
- Not expected to survive > 24 h
- Lack of consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytosorb therapyExtracorporeal treatment with cytosorb filter to patients diagnosed with rhabdomyolysis | Device | cytosorb therapy |
Primary outcome
Syndecan-1
Time frame: 12 hour
Reduction in Syndecan-1 with CS therapy
2 secondary outcomes
glycocalyx markers
Time frame: 12 hour
myoglobin
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Background: PubMed 37918366Albrecht F, Schunk S, Fuchs M, Volk T, Geisel J, Fliser D, Meiser A. Rapid and Effective Elimination of Myoglobin with CytoSorb(R) Hemoadsorber in Patients with Severe Rhabdomyolysis. Blood Purif. 2024;53(2):88-95. doi: 10.1159/000534479. Epub 2023 Nov 2.
- Background: PubMed 12374627D'Agnillo F, Alayash AI. A role for the myoglobin redox cycle in the induction of endothelial cell apoptosis. Free Radic Biol Med. 2002 Oct 15;33(8):1153-64. doi: 10.1016/s0891-5849(02)01007-9.
- Background: PubMed 33595101Hahn RG, Patel V, Dull RO. Human glycocalyx shedding: Systematic review and critical appraisal. Acta Anaesthesiol Scand. 2021 May;65(5):590-606. doi: 10.1111/aas.13797. Epub 2021 Mar 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mustafa altınay study director
şişli etfal eğitim araştırma hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Rhabdomyolysis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 15 Jun 2025. 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 Turkey (Türkiye). 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?
Syndecan-1 (time frame: 12 hour). 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 NCT06503289, 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 15 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.