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Myeloid-Derived Supressor Cells in Cardiac Surgery Patients (MyDeCCS)

Primary Purpose

Insufficiency; Cardiac, Complicating Surgery, Systemic Inflammatory Response Syndrome

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
minimal extracorporeal circulation (MEC)
The cytokines modulations
Sponsored by
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Insufficiency; Cardiac, Complicating Surgery focused on measuring Immune Suppression, Inflammatory Response, Cardiac Surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. the patients with ischemia heart disease and/or valvular heart disease,
  2. signed inform consent,
  3. CABG and/or valve replacement/plastic procedures.

Exclusion Criteria:

1) congenital heart disease.

Sites / Locations

  • Georgy Plotnikov

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Uncomplicated cardiac surgery patients

Complicated cardiac surgery patients

Arm Description

Patients after scheduled cardiac surgery procedures

MECC systems Cytokines modulation by CytoSorb and PMMA membranes

Outcomes

Primary Outcome Measures

MOF-free days

Secondary Outcome Measures

ICU length of stay
the incidents of infection complications

Full Information

First Posted
September 4, 2016
Last Updated
July 18, 2018
Sponsor
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT02902939
Brief Title
Myeloid-Derived Supressor Cells in Cardiac Surgery Patients
Acronym
MyDeCCS
Official Title
Myeloid-Derived Supressor Cells in Uncomplicated vs Complicated Patients After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 19, 2018 (Actual)
Study Completion Date
July 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Institute for Complex Problems of Cardiovascular Diseases, Russia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insufficiency; Cardiac, Complicating Surgery, Systemic Inflammatory Response Syndrome
Keywords
Immune Suppression, Inflammatory Response, Cardiac Surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Uncomplicated cardiac surgery patients
Arm Type
No Intervention
Arm Description
Patients after scheduled cardiac surgery procedures
Arm Title
Complicated cardiac surgery patients
Arm Type
Active Comparator
Arm Description
MECC systems Cytokines modulation by CytoSorb and PMMA membranes
Intervention Type
Device
Intervention Name(s)
minimal extracorporeal circulation (MEC)
Intervention Description
We should use the modification of extracorporeal circulation to reduce the systemic inflammatory response due to excessive haemodilution, allogenic blood transfusion.
Intervention Type
Procedure
Intervention Name(s)
The cytokines modulations
Other Intervention Name(s)
CytoSorb devices,
Intervention Description
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)
Primary Outcome Measure Information:
Title
MOF-free days
Time Frame
28 day
Secondary Outcome Measure Information:
Title
ICU length of stay
Time Frame
28 day
Title
the incidents of infection complications
Time Frame
28 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Georgy Plotnikov
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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Myeloid-Derived Supressor Cells in Cardiac Surgery Patients

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