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Mediastinitis and Staphylococcus Aureus (MEDIASTAPH)

R

Rennes University Hospital

Status

Completed

Conditions

Infection
Surgery, Cardiac

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT03262558
35RC16_9886

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

27 participants in 1 patient group

Patients with ECC
Description:
No intervention
Treatment:
Other: No intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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