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临床试验/NCT06503289
NCT06503289已完成不适用

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

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
1
主要终点
Syndecan-1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Syndecan-1

时间窗: 12 hour

Reduction in Syndecan-1 with CS therapy

次要结局

  • glycocalyx markers(12 hour)
  • myoglobin(12 hours)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olcay Dilken

Anesthesiologist And Intensivist

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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