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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03262558
Other study ID # 35RC16_9886
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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