Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286280
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-02-22
Brief Title:
Removal Of CytoKines With cytoSorbenTs After Inflammatory Response Reaction During Cardiac Surgery
Sponsor:
University of Giessen
Organization:
University of Giessen
Study Overview
Official Title:
Removal of Cytokines With Cytosorbents After Inflammatory Response Reaction During Cardiac Surgery and Association of Endothelial Progenitor Cells
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROCKSTAR
Brief Summary:
Detailed knowledge about the association between systemic inflammation and endothelial progenitor cell EPCs activation during extracorporeal circulation ECC is lacking
This pilot study aims to clarify the relationship between CD34-positive EPCs and cytokine release during ECC using the cytokine adsorber to make a predictive statement regarding the clinical expression of inflammation
This pilot study aims to clarify the relationship between CD34-positive EPCs and cytokine release during ECC using the cytokine adsorber to make a predictive statement regarding the clinical expression of inflammation
Detailed Description:
Mechanical cardiovascular support procedures are used as part of cardiac surgery Here heart-lung machines HLM and miniaturized systems such as ECMO extracorporeal membrane oxygenation are used to replace cardiac andor pulmonary function Contact with non-physiologic artificial surfaces can induce a generalized sterile inflammatory syndrome called SIRS Systemic Inflammatory Response Syndrome During SIRS proinflammatory cytokine release occurs due to complement activation These massively released diverse cytokines significantly influence the activation and release of endothelial progenitor cells EPCs from the bone marrow during extracorporeal circulation ECC and their long-term functionality
The life-threatening complications of the so-called cytokine storm can potentially be avoided with the help of a cytokine adsorber CytoSorb and the stabilization process after the hyperinflammatory phase can be promoted However it is unclear the quantitative and qualitative modification of the cytokine expression pattern by the use of the cytokine adsorber and its influence on the release of EPCs as well as on the clinical course of the patients Although a therapy extension with cytokine adsorber has a positive impact on the reduction of cytokine levels in the blood cytokine removal has not been investigated in direct correlation to EPCs
These interactions are to be investigated within the scope of the proposed project
This project is a pilot study with a translational science background to clarify the relationship between CD34-positive endothelial progenitor cells and cytokine release in the setting of ECCs using cytokine adsorber Previous studies have shown a positive association between increased cytokine levels and the number of circulating endothelial progenitor cells To date it has not been investigated how this correlation or association changes with the use of cytokine adsorbers Therefore due to the specificity of targeted cytokine removal the findings obtained here may provide essential insights in basic clinical research that could be applied to clinical issues and decision-making processes in the future Due to the increasingly important role of extracorporeal circulatory support systems detailed knowledge of the relationship between systemic inflammation and endothelial progenitor cell activation during their use will be increasingly important in the future
The current project aims to investigate whether an association between the inflammatory response during and after cardiac surgery and the number of stem cells EPCs continues to exist when the cytokine adsorber CytoSorb is applied and whether and how the adsorber can influence the functionality migratory capacity and differentiation of stem cells We assume that under these conditions a direct correlation of EPCs with inflammation does not exist so a modulation of the SIRS Systemic Inflammatory Response Syndrome clinically observed by us could be absent In addition we will investigate whether a correlation between the number of circulating endothelial progenitor cells CD 34 cells and the concentration of cytokines can be observed to make a predictive statement regarding the clinical expression of inflammation
The long-term goal is to identify patients at high risk for clinical manifestations of inflammation after using the EPC and based on the knowledge gained make a predictive statement based on the concentration pattern of the EPC
This prospective study should provide information on whether and at which point perioperative hyperinflammation can be reliably predicted and whether establishing a specific cytokine adsorber could positively influence the number of EPCs and thus short- and medium-term survival
The life-threatening complications of the so-called cytokine storm can potentially be avoided with the help of a cytokine adsorber CytoSorb and the stabilization process after the hyperinflammatory phase can be promoted However it is unclear the quantitative and qualitative modification of the cytokine expression pattern by the use of the cytokine adsorber and its influence on the release of EPCs as well as on the clinical course of the patients Although a therapy extension with cytokine adsorber has a positive impact on the reduction of cytokine levels in the blood cytokine removal has not been investigated in direct correlation to EPCs
These interactions are to be investigated within the scope of the proposed project
This project is a pilot study with a translational science background to clarify the relationship between CD34-positive endothelial progenitor cells and cytokine release in the setting of ECCs using cytokine adsorber Previous studies have shown a positive association between increased cytokine levels and the number of circulating endothelial progenitor cells To date it has not been investigated how this correlation or association changes with the use of cytokine adsorbers Therefore due to the specificity of targeted cytokine removal the findings obtained here may provide essential insights in basic clinical research that could be applied to clinical issues and decision-making processes in the future Due to the increasingly important role of extracorporeal circulatory support systems detailed knowledge of the relationship between systemic inflammation and endothelial progenitor cell activation during their use will be increasingly important in the future
The current project aims to investigate whether an association between the inflammatory response during and after cardiac surgery and the number of stem cells EPCs continues to exist when the cytokine adsorber CytoSorb is applied and whether and how the adsorber can influence the functionality migratory capacity and differentiation of stem cells We assume that under these conditions a direct correlation of EPCs with inflammation does not exist so a modulation of the SIRS Systemic Inflammatory Response Syndrome clinically observed by us could be absent In addition we will investigate whether a correlation between the number of circulating endothelial progenitor cells CD 34 cells and the concentration of cytokines can be observed to make a predictive statement regarding the clinical expression of inflammation
The long-term goal is to identify patients at high risk for clinical manifestations of inflammation after using the EPC and based on the knowledge gained make a predictive statement based on the concentration pattern of the EPC
This prospective study should provide information on whether and at which point perioperative hyperinflammation can be reliably predicted and whether establishing a specific cytokine adsorber could positively influence the number of EPCs and thus short- and medium-term survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| F2322 | OTHER_GRANT | German Foundation of Heart Research | None |