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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05182723
• Other study ID #: 20211028-18
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: January 2022
• Source: Petrovsky National Research Centre of Surgery
• Contact: Aleksandr Eremenko, MD
• Phone: +79037129303
• Email: aeremenko54[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 31, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiovascular Diseases
• Inflammation
• Multiple Organ Failure

Intervention

Procedure:
• renal replacement therapy
Extracorporeal Methods for Removing Mediators of Systemic Inflammation

Locations

Country	Name	City	State
Russian Federation	Petrovsky Nacional research Centre of Surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Petrovsky National Research Centre of Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRP	?hange of CRP after 12 hours from baseline value	12 hours from the beginning of the study
Primary	CRP	?hange of CRP after 24 hours from baseline value	24 hours from the beginning of the study
Primary	CRP	comparison of CRP after 12 hours with CRP after 24 hours	24 hours from the beginning of the study
Primary	IL6	?hange of IL6 after 12 hours from baseline value	12 hours from the beginning of the study
Primary	IL6	?hange of IL6 after 24 hours from baseline value	24 hours from the beginning of the study
Primary	IL6	comparison of IL6 after 12 hours with IL6 after 24 hours	24 hours from the beginning of the study
Primary	SOFA	change of SOFA values after 12 hours from baseline value	12 hours from the beginning of the study
Primary	SOFA	change of SOFA values after 24 hours from baseline value	24 hours from the beginning of the study
Primary	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	extracorporeal therapy	duration	hospitalisation period, an average of 1 month
Secondary	time spent in intensive care unit	duration	hospitalisation period, an average of 1 month
Secondary	inpatient stay time	duration	through study completion, an average of 2 months
Secondary	renal function of RIFLE	percentage decrease from initial level	through study completion, an average of 2 months
Secondary	lethality	ratio of the number of deaths to the total number of patients	through study completion, an average of 2 months