Evaluation of the Effectiveness of Extracorporeal Methods for Removing Mediators of Systemic Inflammation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Effectiveness of Extracorporeal Methods for Removing Mediators of Systemic Inflammation in Patient With Multiple Organ Dysfunction Syndrome After Heart and Aortic Surgery

Conditions
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Renal Failure Acute, Multiple Organ Failure, Cardiovascular Diseases

Intervention / Treatment
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* Procedure: renal replacement therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oXiris<br>Monotoring of extracorporeal Method for Removing Mediators of Systemic Inflammation of oXiris will be performed for 24 hours | Procedure: renal replacement therapy<br>* Extracorporeal Methods for Removing Mediators of Systemic Inflammation<br>|
| Experimental: oXiris in combination with Jafron HA330<br>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. | Procedure: renal replacement therapy<br>* Extracorporeal Methods for Removing Mediators of Systemic Inflammation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| SOFA | comparison of the SOFA value after 12 hours with the SOFA value after 24 hours | 24 hours from the beginning of the study | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mediators of systemic inflammation, extracorporeal methods, interleukins