Mediastinitis and Staphylococcus Aureus

NCT03262558 | Completed

• 1 other identifier: 35RC16_9886
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery, Cardiac; Infection

Keywords

staphylococcus aureus; nosocomial infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Variation of phagocytosis capacity of PMNs

  Baseline and the morning following surgery

• Variation of bactericidal capacity of PMNs

  Baseline and the morning following surgery

• Variation of phagocytosis capacity of macrophages

  Baseline and the morning following surgery

• Variation of bactericidal capacity of macrophages

  Baseline and the morning following surgery

• Effect of an inhibitor of IDO on phagocytosis capacities of PMNs

  The day following surgery

Study Arms (1)

Patients with ECC

No intervention

Other: No intervention

Interventions

No intervention OTHER

Patients will undergo standard clinical routine practice in this indication

Patients with ECC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the aftermath of an ECC for cardiac surgery are investigated to look for the origin of a hypo-reactivity of PMNs and macrophages during exposure to staphylococcus aureus

You may qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes Hospital University

Rennes, 35033, France

Location

MeSH Terms

Conditions

Infections; Staphylococcal Infections; Cross Infection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Marc TADIE, Md, PhD

  CHU Rennes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 25, 2017
• Study Start: July 4, 2016
• Primary Completion: July 1, 2017
• Study Completion: September 29, 2019
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)