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

Not Applicable

Recruiting

• Conditions: Renal Failure Acute; Multiple Organ Failure; Cardiovascular Diseases
• Interventions: Procedure: renal replacement therapy

• Registration Number: NCT05182723
• Lead Sponsor: Petrovsky National Research Centre of Surgery

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.

Study Timeline

• Study Start: 2021-11-25
• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-21
• Status Verified: 2022-01
• Study First Posted: 2022-01-10
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-02-03
• Primary Completion: 2024-11-30
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oXiris	renal replacement therapy	Monotoring of extracorporeal Method for Removing Mediators of Systemic Inflammation of oXiris will be performed for 24 hours
oXiris in combination with Jafron HA330	renal replacement therapy	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.

Primary Outcome Measures

Name	Time	Method
IL6	24 hours from the beginning of the study	comparison of IL6 after 12 hours with IL6 after 24 hours
CRP	24 hours from the beginning of the study	comparison of CRP after 12 hours with CRP after 24 hours
SOFA	24 hours from the beginning of the study	comparison of the SOFA value after 12 hours with the SOFA value after 24 hours

Secondary Outcome Measures

Name	Time	Method
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
extracorporeal therapy	hospitalisation period, an average of 1 month	duration
renal function of RIFLE	through study completion, an average of 2 months	percentage decrease from initial level
lethality	through study completion, an average of 2 months	ratio of the number of deaths to the total number of patients

Trial Locations

Locations (1)

Petrovsky Nacional research Centre of Surgery; 🇷🇺 Moscow, Russian Federation