Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oXiris | Active Comparator | Monotoring of extracorporeal Method for Removing Mediators of Systemic Inflammation of oXiris will be performed for 24 hours |
|
| oXiris in combination with Jafron HA330 | Experimental | Extracorporeal Method for Removing Mediators of Systemic Inflammation oXiris in combination with Jafron HA330 will be performed for 4 hours. If SOFA is more or equally 4 , CRP is more than 100 ng/ml;, the IL6 value is increased by 5 or more times after 12 hours of procedure Jafron HA330 will be reconnected and performed for 4 hours. Monitoring of whole procedure will be performed for 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| renal replacement therapy | Procedure | Extracorporeal Methods for Removing Mediators of Systemic Inflammation |
|
| Measure | Description | Time Frame |
|---|---|---|
| CRP | сhange of CRP after 12 hours from baseline value | 12 hours from the beginning of the study |
| CRP | сhange of CRP after 24 hours from baseline value | 24 hours from the beginning of the study |
| CRP | comparison of CRP after 12 hours with CRP after 24 hours | 24 hours from the beginning of the study |
| IL6 | сhange of IL6 after 12 hours from baseline value | 12 hours from the beginning of the study |
| IL6 | сhange of IL6 after 24 hours from baseline value | 24 hours from the beginning of the study |
| IL6 | comparison of IL6 after 12 hours with IL6 after 24 hours | 24 hours from the beginning of the study |
| SOFA | change of SOFA values after 12 hours from baseline value | 12 hours from the beginning of the study |
| SOFA | change of SOFA values after 24 hours from baseline value | 24 hours from the beginning of the study |
| Measure | Description | Time Frame |
|---|---|---|
| extracorporeal therapy | duration | hospitalisation period, an average of 1 month |
| time spent in intensive care unit | duration | hospitalisation period, an average of 1 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksandr Eremenko, MD | Contact | +79037129303 | aeremenko54@mail.ru | |
| Tatiana Marchenko | Contact | +79651077860 | marta2810@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Aleksandr Eremenko, MD | Petrovsky National Research Centre of Surgery | Study Director |
| Tatiana Marchenko | Petrovsky National Research Centre of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Petrovsky Nacional research Centre of Surgery | Recruiting | Moscow | 119991 | Russia |
Not provided
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D009102 | Multiple Organ Failure |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SOFA |
comparison of the SOFA value after 12 hours with the SOFA value after 24 hours |
| 24 hours from the beginning of the study |
| inpatient stay time | duration | through study completion, an average of 2 months |
| renal function of RIFLE | percentage decrease from initial level | through study completion, an average of 2 months |
| lethality | ratio of the number of deaths to the total number of patients | through study completion, an average of 2 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |