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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Evgeny Grigoryev, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Sponsor:
Information provided by (Responsible Party):
Evgeny Grigoryev, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
ClinicalTrials.gov Identifier:
NCT02902939
First received: September 4, 2016
Last updated: September 24, 2016
Last verified: September 2016
  Purpose

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 Intervention Phase
Insufficiency; Cardiac, Complicating Surgery Systemic Inflammatory Response Syndrome Device: minimal extracorporeal circulation (MEC) Procedure: The cytokines modulations Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Myeloid-Derived Supressor Cells in Uncomplicated vs Complicated Patients After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Evgeny Grigoryev, Research Institute for Complex Problems of Cardiovascular Diseases, Russia:

Primary Outcome Measures:
  • MOF-free days [ Time Frame: 28 day ]

Secondary Outcome Measures:
  • ICU length of stay [ Time Frame: 28 day ]
  • the incidents of infection complications [ Time Frame: 28 day ]

Estimated Enrollment: 100
Study Start Date: September 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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,

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02902939

Contacts
Contact: Evgeny V Grigoryev, MD PhD +3842643604 grigorievev@hotmail.com
Contact: Dmitriy L Shukevich, MD PhD +73842643308 shukdl@kemcardio.ru

Locations
Russian Federation
Georgy Plotnikov Recruiting
Kemerovo, Russian Federation, 650002
Contact: Georgy V Plotnikov         
Sponsors and Collaborators
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
  More Information

Responsible Party: Evgeny Grigoryev, professor, the deputy director for scientific and clinical affairs, senior research specialist, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
ClinicalTrials.gov Identifier: NCT02902939     History of Changes
Other Study ID Numbers: 20161101
Study First Received: September 4, 2016
Last Updated: September 24, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Evgeny Grigoryev, Research Institute for Complex Problems of Cardiovascular Diseases, Russia:
Immune Suppression, Inflammatory Response, Cardiac Surgery

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Heart Failure
Inflammation
Pathologic Processes
Shock
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 19, 2017