Skip to main content
OpenTrials
Completed

NCT Number: NCT03262558

Mediastinitis and Staphylococcus Aureus

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgery, Cardiac Bacterial Infections Bacterial Infections and Mycoses Cross Infection Disease Attributes Gram-Positive Bacterial Infections Iatrogenic Disease Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Staphylococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rennes Hospital University

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

Patients will undergo standard clinical routine practice in this indication

Primary outcomes

  1. Variation of plasma IDO activity

    Time frame: Baseline and the morning following surgery

    IDO 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 outcomes

  1. Variation of phagocytosis capacity of PMNs

    Time frame: Baseline and the morning following surgery

    Comparison before and after ECC

  2. Variation of bactericidal capacity of PMNs

    Time frame: Baseline and the morning following surgery

    Comparison before and after ECC

  3. Variation of phagocytosis capacity of macrophages

    Time frame: Baseline and the morning following surgery

    Comparison before and after ECC

  4. Variation of bactericidal capacity of macrophages

    Time frame: Baseline and the morning following surgery

    Comparison before and after ECC

  5. Effect of an inhibitor of IDO on phagocytosis capacities of PMNs

    Time frame: The day following surgery

  6. Effect of an inhibitor of IDO on bactericidal capacities of PMNs

    Time frame: The day following surgery

  7. Effect of an inhibitor of IDO on phagocytosis capacities of macrophages

    Time frame: The day following surgery

  8. Effect of an inhibitor of IDO on bactericidal capacities of macrophages

    Time frame: The day following surgery

  9. Quantification of lymphocytic apoptosis before and after the ECC

    Time frame: Baseline and the morning following surgery

    Quantification of apoptosis by flow cytometry

  10. Quantification of lymphocytic apoptosis in the presence of an inhibitor of IDO

    Time frame: The day following surgery

    Quantification of apoptosis by flow cytometry

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: MEDIASTAPH

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Aug 25, 2017
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.