Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503289
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Myoglobin Removal With CytoSorb in Rhabdomyolysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of The Removal of Myoglobin With CytoSorb on The Endothelium and Glycocalyx Shedding Biomarkers in Patients With Rhabdomyolysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
- 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None