Mediastinitis and Staphylococcus Aureus

NCT ID: NCT03262558

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-04

Study Completion Date

2019-09-29

Brief Summary

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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

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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

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Surgery, Cardiac Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with ECC

No intervention

No intervention

Intervention Type OTHER

Patients will undergo standard clinical routine practice in this indication

Interventions

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No intervention

Patients will undergo standard clinical routine practice in this indication

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age
* Patients who require cardiac surgery (valvular and / or coronary) with extracorporeal circulation.


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Marc TADIE, Md, PhD

Role: STUDY_DIRECTOR

CHU Rennes

Locations

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Rennes Hospital University

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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35RC16_9886

Identifier Type: -

Identifier Source: org_study_id

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