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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Multiple Organ Failure; Renal Failure Acute
• Intervention / Treatment: Procedure: renal replacement therapy

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tatiana Marchenko; Phone Number: +79651077860; Email: marta2810@gmail.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Recruiting
    • Petrovsky Nacional research Centre of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Petrovsky National Research Centre of Surgery
• Investigators: Principal Investigator: Tatiana Marchenko, Petrovsky National Research Centre of Surgery

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Anticipated): November 30, 2024
• Study Completion (Anticipated): May 31, 2025

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: interleukins; mediators of systemic inflammation; extracorporeal methods
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Shock; Cardiovascular Diseases; Inflammation; Acute Kidney Injury; Multiple Organ Failure
• Other Study ID Numbers: 20211028-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No