Insufficiency; Cardiac, Complicating SurgeryMyDeCCSNCT02902939
Myeloid-Derived Supressor Cells in Cardiac Surgery Patients
A study testing minimal extracorporeal circulation (MEC) and The cytokines modulations in people with Insufficiency; Cardiac, Complicating Surgery and Systemic Inflammatory Response Syndrome, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Insufficiency; Cardiac, Complicating Surgery, Systemic Inflammatory Response Syndrome
- What is being tested?
- minimal extracorporeal circulation (MEC) and The cytokines modulations
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2016to 19 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients with ischemia heart disease and/or valvular heart disease,
- signed inform consent,
- CABG and/or valve replacement/plastic procedures.
Who cannot join
- 1) congenital heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- minimal extracorporeal circulation (MEC), The cytokines modulations
- Keywords
- Immune Suppression, Inflammatory Response, Cardiac Surgery
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimal extracorporeal circulation (MEC)Device
We should use the modification of extracorporeal circulation to reduce the systemic inflammatory response due to excessive haemodilution, allogenic blood transfusion.
The cytokines modulationsProcedure or surgery
Also called CytoSorb devices,
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)
| Study group | Role | What they receive |
|---|---|---|
| Uncomplicated cardiac surgery patients | No intervention | Patients after scheduled cardiac surgery procedures |
| Complicated cardiac surgery patients | Active comparator | MECC systems Cytokines modulation by CytoSorb and PMMA membranes Receives: Device: minimal extracorporeal circulation (MEC); Procedure: The cytokines modulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOF-free days
Measured: 28 day
Secondary outcomes (2)
ICU length of stay
Measured: 28 day
the incidents of infection complications
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion19 Jul 2018
- Study completion19 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insufficiency; Cardiac, Complicating SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evgeny Grigoryev, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902939
- Sponsor's protocol ID
- 20161101
- Acronym
- MyDeCCS
- Status last verified
- Jul 2018
- First submitted
- 4 Sep 2016
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloid-Derived Supressor Cells in Uncomplicated vs Complicated Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02902939
- Acronym / sponsor ID
- MyDeCCS / 20161101
- Keywords
- Immune Suppression, Inflammatory Response, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, RussiaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 19 Jul 2018 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uncomplicated cardiac surgery patients | No intervention | –Patients after scheduled cardiac surgery procedures |
| Complicated cardiac surgery patients | Active comparator | Device: minimal extracorporeal circulation (MEC), Procedure: The cytokines modulationsMECC systems Cytokines modulation by CytoSorb and PMMA membranes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the patients with ischemia heart disease and/or valvular heart disease,
- signed inform consent,
- CABG and/or valve replacement/plastic procedures.
Key exclusion criteria (1 listed)
- 1) congenital heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Complicated cardiac surgery patients |
| The cytokines modulationsAlso: CytoSorb devices,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) | Procedure or surgery | Complicated cardiac surgery patients |
Primary outcome
MOF-free days
Time frame: 28 day
2 secondary outcomes
ICU length of stay
Time frame: 28 day
the incidents of infection complications
Time frame: 28 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimal extracorporeal circulation (MEC) and The cytokines modulations in people with Insufficiency; Cardiac, Complicating Surgery and Systemic Inflammatory Response Syndrome, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOF-free days (time frame: 28 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.