Clinical trial NCT06503289: Myoglobin Removal With CytoSorb in Rhabdomyolysis
Official title: Effects of The Removal of Myoglobin With CytoSorb on The Endothelium and Glycocalyx Shedding Biomarkers in Patients With Rhabdomyolysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Rhabdomyolysis
Endothelial Dysfunction
Keywords: Myoglobin
Rhabdomyolysis
Acute Kidney Injury
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18 years and older patients who need cytosorb therapy due to rhadomyolysis

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Syndecan-1
timeFrame: 12 hour
Secondary outcomes:
measure: glycocalyx markers
timeFrame: 12 hour
measure: myoglobin
timeFrame: 12 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli etfal research and training hospital
Study officials:
affiliation: şişli etfal eğitim araştırma hastanesi
name: mustafa altınay
role: STUDY_DIRECTOR
References:
citation: 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.
citation: D'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.
citation: Hahn 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.