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

Petrovsky National Research Centre of Surgery

Status: Enrolling

Conditions: Multiple Organ Failure; Cardiovascular Diseases; Renal Failure Acute

Treatments: Procedure: renal replacement therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05182723

20211028-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

oXiris

Active Comparator group

Description:

Monotoring of extracorporeal Method for Removing Mediators of Systemic Inflammation of oXiris will be performed for 24 hours

Treatment:

Procedure: renal replacement therapy

oXiris in combination with Jafron HA330

Experimental group

Description:

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.

Treatment:

Procedure: renal replacement therapy