Myeloid-Derived Supressor Cells in Cardiac Surgery Patients (MyDeCCS)
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|ClinicalTrials.gov Identifier: NCT02902939|
Recruitment Status : Recruiting
First Posted : September 16, 2016
Last Update Posted : September 27, 2016
Pro- and anti-inflammatory response during the formation of the critical state develops at the same time. Because of its balanced or unbalanced systemic inflammation can be either aborted or able to lead to multiple organ failure. With regard to sepsis, systemic inflammatory response characteristics are well understood, is not achieved in respect of the "sterile" inflammation.
Extracorporeal circulation is a clinical model of systemic inflammatory response due to non-physiological activation of tissue factor in the extracorporeal perfusion, the use of non-pulsatile circulation mode, intentional / unintentional hypothermia, bacterial translocation from the gastrointestinal tract and perfusion deficit.
We have proved that the monocytes demonstrate suppressor function, which can be a predictor of complications from cardiac surgery patients.
The most important component of the formation of multiple organ failure (MOF) in critically ill patients is immunosuppression.
During the study of experimental and clinical tumor growth process scientists has provided a new population of immature myeloid cells (myeloid suppressor cells or suppressor cells of myeloid origin, MDSC). Most of the works have been devoted to the role of MDSC in the development of tumors, where it has been clearly shown that this cell population has an undoubted effect of immune suppression. However, recent studies show that the role of MDSC is not limited to cancer process, but extends to chronic or acute inflammation.
The aim of this study is to determine the role of MDSC in the development of immune suppression and complications after heart surgery carried out under cardiopulmonary bypass.
|Condition or disease||Intervention/treatment||Phase|
|Insufficiency; Cardiac, Complicating Surgery Systemic Inflammatory Response Syndrome||Device: minimal extracorporeal circulation (MEC) Procedure: The cytokines modulations||Phase 4|
The use of MEC systems can be useful to prevent the MDSC activation after cardiac surgery.
The procedures to modulate the cytokines concentration can be useful to prevent the MDSC activation after cardiac surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Myeloid-Derived Supressor Cells in Uncomplicated vs Complicated Patients After Cardiac Surgery|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||December 2017|
No Intervention: Uncomplicated cardiac surgery patients
Patients after scheduled cardiac surgery procedures
Active Comparator: Complicated cardiac surgery patients
MECC systems Cytokines modulation by CytoSorb and PMMA membranes
Device: minimal extracorporeal circulation (MEC)
We should use the modification of extracorporeal circulation to reduce the systemic inflammatory response due to excessive haemodilution, allogenic blood transfusion.Procedure: The cytokines modulations
We should use the modification of cytokines by CytoSorb devices and cytokines removal by PMMA membranes during extracorporeal circulation in patients with risk factors of complications (long duration of extracorporeal circulation, re-do procedures and other)
Other Name: CytoSorb devices,
- MOF-free days [ Time Frame: 28 day ]
- ICU length of stay [ Time Frame: 28 day ]
- the incidents of infection complications [ Time Frame: 28 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902939
|Contact: Evgeny V Grigoryev, MD PhDfirstname.lastname@example.org|
|Contact: Dmitriy L Shukevich, MD PhDemail@example.com|
|Kemerovo, Russian Federation, 650002|
|Contact: Georgy V Plotnikov|