Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT03262558
Status:
COMPLETED
Last Update Posted:
2022-12-14
First Post:
2017-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mediastinitis and Staphylococcus Aureus
Sponsor:
Rennes University Hospital
Organization:
Study Overview
Official Title:
Immunological and Bacteriological Approaches to the Development of Postoperative Mediastinitis With Staphylococcus Aureus
Status:
COMPLETED
Status Verified Date:
2022-12
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:
MEDIASTAPH
Brief Summary:
Cardiac surgery with extracorporeal circulation (ECC) yields a deep immune system dysfunction that exposes patients to postoperative infectious complications. Among these, post-operative mediastinitis with Staphylococcus aureus (SA) generates significant morbidity and mortality. Two radically different approaches have been proposed in recent years to reduce the incidence of this complication. A first approach has attempted, without real success, to decrease postoperative immunosuppression. The second, more efficient, consisted of screening and preoperatively treating patients colonized with SA. However, although its incidence has decreased, postoperative mediastinitis remains a terrible nosocomial infection. The authors believe that a thorough analysis of the immunological changes induced by cardiac surgery will initiate active therapeutics to reduce the post-operative immunosuppression phase, thereby decreasing the risk of nosocomial infections. In addition, a study of the interactions between the operated (host) and staphylococcus aureus (pathogenic) immune systems will provide a better understanding of the mechanisms that expose patients to this bacterium.
Detailed Description:
In particular, changes induced by the ECC will be evaluated on:
* Indoleamine 2,3-dioxygenase activity (IDO)
* Apoptosis of lymphocytes and dendritic cells
* Polymorphonuclear neutrophils (PMNs)
* Myeloid Derived Suppressor Cells (MDSC )
After general anesthesia and arterial catheterization and prior to the start of ECC, blood samples will be taken for flow cytometry studies, for the purification of PMNs and monocytes. The purified PMNs and monocytes will then be used for the measurement of cytokine, phagocytosis and bactericidal production capacities.
The morning following surgery, blood samples will be taken and follow the same process.
* Indoleamine 2,3-dioxygenase activity (IDO)
* Apoptosis of lymphocytes and dendritic cells
* Polymorphonuclear neutrophils (PMNs)
* Myeloid Derived Suppressor Cells (MDSC )
After general anesthesia and arterial catheterization and prior to the start of ECC, blood samples will be taken for flow cytometry studies, for the purification of PMNs and monocytes. The purified PMNs and monocytes will then be used for the measurement of cytokine, phagocytosis and bactericidal production capacities.
The morning following surgery, blood samples will be taken and follow the same process.
Study Oversight
Has Oversight DMC:
False
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?: