Myeloid-Derived Supressor Cells in Cardiac Surgery Patients

Systemic Inflammatory Response Syndrome Clinical Trial

— MyDeCCS  

Official title:

Myeloid-Derived Supressor Cells in Uncomplicated vs Complicated Patients After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902939
• Other study ID #: 20161101
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: July 19, 2018

Study information

• Verified date: July 2018
• Source: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 19, 2018
• Est. primary completion date: July 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Insufficiency; Cardiac, Complicating Surgery
• Systemic Inflammatory Response Syndrome

Intervention

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)

Locations

Country	Name	City	State
Russian Federation	Georgy Plotnikov	Kemerovo

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MOF-free days		28 day
Secondary	ICU length of stay		28 day
Secondary	the incidents of infection complications		28 day