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Mediastinitis and Staphylococcus Aureus

Immunological and Bacteriological Approaches to the Development of Postoperative Mediastinitis With Staphylococcus Aureus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03262558
Acronym
MEDIASTAPH
Enrollment
27
Registered
2017-08-25
Start date
2016-07-04
Completion date
2019-09-29
Last updated
2022-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Surgery, Cardiac

Keywords

staphylococcus aureus, nosocomial infection

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.

Interventions

OTHERNo intervention

Patients will undergo standard clinical routine practice in this indication

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients over 18 years of age * Patients who require cardiac surgery (valvular and / or coronary) with extracorporeal circulation. Non inclusion criteria * Chronic respiratory diseases, * Preoperative left ventricular dysfunction (LVEF \<50%), * Immunosuppression (HIV infection, systemic corticosteroid therapy, history of cancer in the year before surgery), * Persons subject to legal protection (safeguard of justice, curatorship, guardianship), * Persons deprived of liberty.

Design outcomes

Primary

MeasureTime frameDescription
Variation of plasma IDO activityBaseline and the morning following surgeryIDO activity is evaluated by the Kynurenin / Tryptophan ratio before and after ECC. Enzymatic activities will be measured by high performance liquid chromatography (HPLC) on pre- and post-operative blood tests

Secondary

MeasureTime frameDescription
Variation of bactericidal capacity of PMNsBaseline and the morning following surgeryComparison before and after ECC
Variation of phagocytosis capacity of macrophagesBaseline and the morning following surgeryComparison before and after ECC
Variation of bactericidal capacity of macrophagesBaseline and the morning following surgeryComparison before and after ECC
Effect of an inhibitor of IDO on phagocytosis capacities of PMNsThe day following surgery
Variation of phagocytosis capacity of PMNsBaseline and the morning following surgeryComparison before and after ECC
Effect of an inhibitor of IDO on phagocytosis capacities of macrophagesThe day following surgery
Effect of an inhibitor of IDO on bactericidal capacities of macrophagesThe day following surgery
Quantification of lymphocytic apoptosis before and after the ECCBaseline and the morning following surgeryQuantification of apoptosis by flow cytometry
Quantification of lymphocytic apoptosis in the presence of an inhibitor of IDOThe day following surgeryQuantification of apoptosis by flow cytometry
Effect of an inhibitor of IDO on bactericidal capacities of PMNsThe day following surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026