Surgery, CardiacMEDIASTAPHNCT03262558
Mediastinitis and Staphylococcus Aureus
An observational study of Surgery, Cardiac and Infection, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Cardiac, Infection
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2016to 29 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery, Cardiac, Infection
- Being tested
- No intervention
- Keywords
- staphylococcus aureus, nosocomial infection
- Medical subject headings
- Infections, Staphylococcal Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Patients will undergo standard clinical routine practice in this indication
| Study group | Role | What they receive |
|---|---|---|
| Patients with ECC | No intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and the morning following surgery
Secondary outcomes (10)
Variation of phagocytosis capacity of PMNs
Comparison before and after ECC
Measured: Baseline and the morning following surgery
Variation of bactericidal capacity of PMNs
Comparison before and after ECC
Measured: Baseline and the morning following surgery
Variation of phagocytosis capacity of macrophages
Comparison before and after ECC
Measured: Baseline and the morning following surgery
Variation of bactericidal capacity of macrophages
Comparison before and after ECC
Measured: Baseline and the morning following surgery
Effect of an inhibitor of IDO on phagocytosis capacities of PMNs
Measured: The day following surgery
Effect of an inhibitor of IDO on bactericidal capacities of PMNs
Measured: The day following surgery
Effect of an inhibitor of IDO on phagocytosis capacities of macrophages
Measured: The day following surgery
Effect of an inhibitor of IDO on bactericidal capacities of macrophages
Measured: The day following surgery
Quantification of lymphocytic apoptosis before and after the ECC
Quantification of apoptosis by flow cytometry
Measured: Baseline and the morning following surgery
Quantification of lymphocytic apoptosis in the presence of an inhibitor of IDO
Quantification of apoptosis by flow cytometry
Measured: The day following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start4 Jul 2016
- Primary completion1 Jul 2017
- Study completion29 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc TADIE, Md, PhD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262558
- Sponsor's protocol ID
- 35RC16_9886
- Acronym
- MEDIASTAPH
- Status last verified
- Dec 2022
- First submitted
- 22 Aug 2017
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological and Bacteriological Approaches to the Development of Postoperative Mediastinitis With Staphylococcus Aureus
- ClinicalTrials.gov ID
- NCT03262558
- Acronym / sponsor ID
- MEDIASTAPH / 35RC16_9886
- Conditions
- Surgery, Cardiac, Infection
- Keywords
- staphylococcus aureus, nosocomial infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 4 Jul 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 29 Sep 2019 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ECC | – | Other: No interventionNo intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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%),
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionPatients will undergo standard clinical routine practice in this indication | Other | Patients with ECC |
Primary outcome
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
10 secondary outcomes
Variation of phagocytosis capacity of PMNs
Time frame: Baseline and the morning following surgery
Variation of bactericidal capacity of PMNs
Time frame: Baseline and the morning following surgery
Variation of phagocytosis capacity of macrophages
Time frame: Baseline and the morning following surgery
Variation of bactericidal capacity of macrophages
Time frame: Baseline and the morning following surgery
Effect of an inhibitor of IDO on phagocytosis capacities of PMNs
Time frame: The day following surgery
Effect of an inhibitor of IDO on bactericidal capacities of PMNs
Time frame: The day following surgery
Effect of an inhibitor of IDO on phagocytosis capacities of macrophages
Time frame: The day following surgery
Effect of an inhibitor of IDO on bactericidal capacities of macrophages
Time frame: The day following surgery
Quantification of lymphocytic apoptosis before and after the ECC
Time frame: Baseline and the morning following surgery
Quantification of lymphocytic apoptosis in the presence of an inhibitor of IDO
Time frame: The day following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Surgery, Cardiac
Active, not recruitingPhase 2/3
Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
Comparative Effectiveness
RecruitingPhase 2
Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.
Chirurgical Intervention, Thrombocytopaenia
Not yet recruitingObservational study
Biomarkers of Postoperative Complications After Cardiac Surgery
Postoperative Complications
Recruiting
Early Cardiopulmonary Rehabilitation Bundle Functional Capacity and Outcomes of Cardiac Surgeries Patients
Cardiac Surgeries
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc TADIE, Md, PhD study director
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, Cardiac and Infection, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of plasma IDO activity (time frame: Baseline and the morning following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.