Mediastinitis and Staphylococcus Aureus

Infection Clinical Trial

— MEDIASTAPH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262558
• Other study ID #: 35RC16_9886
• Status: Completed
• Start date: July 4, 2016
• Est. completion date: September 29, 2019

Study information

• Verified date: December 2022
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 29, 2019
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infection
• Mediastinitis
• Surgery, Cardiac

Intervention

Other:
• No intervention
Patients will undergo standard clinical routine practice in this indication

Locations

Country	Name	City	State
France	Rennes Hospital University	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of plasma IDO activity	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	Baseline and the morning following surgery
Secondary	Variation of phagocytosis capacity of PMNs	Comparison before and after ECC	Baseline and the morning following surgery
Secondary	Variation of bactericidal capacity of PMNs	Comparison before and after ECC	Baseline and the morning following surgery
Secondary	Variation of phagocytosis capacity of macrophages	Comparison before and after ECC	Baseline and the morning following surgery
Secondary	Variation of bactericidal capacity of macrophages	Comparison before and after ECC	Baseline and the morning following surgery
Secondary	Effect of an inhibitor of IDO on phagocytosis capacities of PMNs		The day following surgery
Secondary	Effect of an inhibitor of IDO on bactericidal capacities of PMNs		The day following surgery
Secondary	Effect of an inhibitor of IDO on phagocytosis capacities of macrophages		The day following surgery
Secondary	Effect of an inhibitor of IDO on bactericidal capacities of macrophages		The day following surgery
Secondary	Quantification of lymphocytic apoptosis before and after the ECC	Quantification of apoptosis by flow cytometry	Baseline and the morning following surgery
Secondary	Quantification of lymphocytic apoptosis in the presence of an inhibitor of IDO	Quantification of apoptosis by flow cytometry	The day following surgery