Mediastinitis and Staphylococcus Aureus (MEDIASTAPH)

December 13, 2022 updated by: Rennes University Hospital

Immunological and Bacteriological Approaches to the Development of Postoperative Mediastinitis With 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Rennes Hospital University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with ECC
No intervention
Other: No intervention
Patients will undergo standard clinical routine practice in this indication

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline and the morning following surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Variation of phagocytosis capacity of PMNs
Time Frame: Baseline and the morning following surgery
Comparison before and after ECC
Baseline and the morning following surgery
Variation of bactericidal capacity of PMNs
Time Frame: Baseline and the morning following surgery
Comparison before and after ECC
Baseline and the morning following surgery
Variation of phagocytosis capacity of macrophages
Time Frame: Baseline and the morning following surgery
Comparison before and after ECC
Baseline and the morning following surgery
Variation of bactericidal capacity of macrophages
Time Frame: Baseline and the morning following surgery
Comparison before and after ECC
Baseline and the morning following surgery
Effect of an inhibitor of IDO on phagocytosis capacities of PMNs
Time Frame: The day following surgery
The day following surgery
Effect of an inhibitor of IDO on bactericidal capacities of PMNs
Time Frame: The day following surgery
The day following surgery
Effect of an inhibitor of IDO on phagocytosis capacities of macrophages
Time Frame: The day following surgery
The day following surgery
Effect of an inhibitor of IDO on bactericidal capacities of macrophages
Time Frame: The day following surgery
The day following surgery
Quantification of lymphocytic apoptosis before and after the ECC
Time Frame: Baseline and the morning following surgery
Quantification of apoptosis by flow cytometry
Baseline and the morning following surgery
Quantification of lymphocytic apoptosis in the presence of an inhibitor of IDO
Time Frame: The day following surgery
Quantification of apoptosis by flow cytometry
The day following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rennes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jean-Marc TADIE, Md, PhD, Chu Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 35RC16_9886

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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