- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02902939
Myeloid-Derived Supressor Cells in Cardiac Surgery Patients (MyDeCCS)
Myeloid-Derived Supressor Cells in Uncomplicated vs Complicated Patients After Cardiac Surgery
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kemerovo, Russian Federation, 650002
- Georgy Plotnikov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- the patients with ischemia heart disease and/or valvular heart disease,
- signed inform consent,
- CABG and/or valve replacement/plastic procedures.
Exclusion Criteria:
1) congenital heart disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
We should use the modification of extracorporeal circulation to reduce the systemic inflammatory response due to excessive haemodilution, allogenic blood transfusion.
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MOF-free days
Time Frame: 28 day
|
28 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ICU length of stay
Time Frame: 28 day
|
28 day
|
the incidents of infection complications
Time Frame: 28 day
|
28 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20161101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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