An observational study in Surgery, Cardiac and Infection, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-14.
Sponsored by Rennes University Hospital · Observational
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.
In particular, changes induced by the ECC will be evaluated on:
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.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's enrollment of 27 is below the median of 300 across 685 observational studies indexed under Infections.
Browse Infections studies →Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Inclusion criteria
Non inclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention
Other: No intervention
Patients will undergo standard clinical routine practice in this indication
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
Time frame: Baseline and the morning following surgery
Variation of phagocytosis capacity of PMNs
Comparison before and after ECC
Time frame: Baseline and the morning following surgery
Variation of bactericidal capacity of PMNs
Comparison before and after ECC
Time frame: Baseline and the morning following surgery
Variation of phagocytosis capacity of macrophages
Comparison before and after ECC
Time frame: Baseline and the morning following surgery
Variation of bactericidal capacity of macrophages
Comparison before and after ECC
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
Quantification of apoptosis by flow cytometry
Time frame: Baseline and the morning following surgery
Quantification of lymphocytic apoptosis in the presence of an inhibitor of IDO
Quantification of apoptosis by flow cytometry
Time frame: The day following surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2016 to primary completion in Jul 2017, 11 months.
Of 257 non-industry observational studies under Infections, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 79. This study's 11 months is below that.
Counting every sponsor, half of 295 studies reached it within 35 months; a quarter within 18 and three quarters within 67.
Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.