Trials / Completed
CompletedNCT03262558
Mediastinitis and Staphylococcus Aureus
Immunological and Bacteriological Approaches to the Development of Postoperative Mediastinitis With Staphylococcus Aureus
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 27 (actual)
- Sponsor
- Rennes University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention | Patients will undergo standard clinical routine practice in this indication |
Timeline
- Start date
- 2016-07-04
- Primary completion
- 2017-07-01
- Completion
- 2019-09-29
- First posted
- 2017-08-25
- Last updated
- 2022-12-14
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03262558. Inclusion in this directory is not an endorsement.