Cardiovascular Diseases, Multiple Organ Failure, Renal Failure Acute
Conditions
Keywords
mediators of systemic inflammation, extracorporeal methods, interleukins
Brief summary
The purpose of this study is to assess the effectiveness and the safety of extracorporeal methods for removing mediators of systemic inflammation in patients with multiple organ dysfunction syndrome after heart and aorta surgery.
Detailed description
After being informed about the study and potential risk, all patients with multiple organ dysfunction syndrome after heart and aorta surgery with indications for extracorporeal removal of inflammatory mediators, giving written informed consent will be included in the study. Patients will be randomized 1:1 ratio to 1. hemoperfusion cartridge for cytokine sorption in combination with an oXiris membrane and 2. oXiris membrane.
Interventions
PROCEDURErenal replacement therapy
Extracorporeal Methods for Removing Mediators of Systemic Inflammation
Sponsors
Petrovsky National Research Centre of Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* multiple organ dysfunction; * SOFA equal to or more than 4; * CRP equal to or more than 100 ng / ml; * increase of IL6 by 5 times or more
Exclusion criteria
* the impossibility to use heparin ( bleeding; heparin-induced thrombocytopenia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRP | 12 hours from the beginning of the study | сhange of CRP after 12 hours from baseline value |
| IL6 | 12 hours from the beginning of the study | сhange of IL6 after 12 hours from baseline value |
| SOFA | 12 hours from the beginning of the study | change of SOFA values after 12 hours from baseline value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| renal function of RIFLE | through study completion, an average of 2 months | percentage decrease from initial level |
| extracorporeal therapy | hospitalisation period, an average of 1 month | duration |
| lethality | through study completion, an average of 2 months | ratio of the number of deaths to the total number of patients |
| time spent in intensive care unit | hospitalisation period, an average of 1 month | duration |
| inpatient stay time | through study completion, an average of 2 months | duration |
Countries
Russia
Contacts
Primary ContactAleksandr Eremenko, MD
Backup ContactTatiana Marchenko
Outcome results
None listed