Myoglobin Removal With CytoSorb in Rhabdomyolysis

NCT06503289 | Completed

• 1 other identifier: 2346
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Rhabdomyolysis; Endothelial Dysfunction

Keywords

Myoglobin; Rhabdomyolysis; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Syndecan-1

  Reduction in Syndecan-1 with CS therapy

  12 hour

Secondary Outcomes (2)

• glycocalyx markers

  12 hour

• myoglobin

  12 hours

Study Arms (1)

cytosorb therapy

18 years older patients who need cytsorb therapy due to rhabdomyolysis

Device: Cytosorb therapy

Interventions

Cytosorb therapy DEVICE

Extracorporeal treatment with cytosorb filter to patients diagnosed with rhabdomyolysis

cytosorb therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients with Creatine Kinase \> 5000 IU/L.
• GFR below 40 ml/min.

You may not qualify if:

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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli etfal research and training hospital

Istanbul, 34371, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 37918366 BACKGROUND

• 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.

  PMID: 12374627 BACKGROUND

• 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.

  PMID: 33595101 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Rhabdomyolysis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• mustafa altınay

  şişli etfal eğitim araştırma hastanesi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist And Intensivist

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: August 1, 2024
• Primary Completion: January 22, 2025
• Study Completion: May 1, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)