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

NCT05182723 — Not applicable, Unknown, 20 participants, Petrovsky National Research Centre of Surgery

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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

Registry	NCT05182723
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	20 (Estimated)
Sponsor	Petrovsky National Research Centre of Surgery (Other)
Conditions	Renal Failure Acute, Multiple Organ Failure, Cardiovascular Diseases
Interventions	renal replacement therapy (Procedure)
Dates	start 2021-11-25, primary completion 2024-11-30 (estimated), completion 2025-05-31 (estimated), first posted 2022-01-10, last updated 2022-02-03
Locations	1 site in Russia

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
oXiris	Active comparator	Procedure: 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	Experimental	Procedure: 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.

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

+Outcome measures

Primary outcomes

CRP [12 hours from the beginning of the study]: сhange of CRP after 12 hours from baseline value
CRP [24 hours from the beginning of the study]: сhange of CRP after 24 hours from baseline value
CRP [24 hours from the beginning of the study]: comparison of CRP after 12 hours with CRP after 24 hours
IL6 [12 hours from the beginning of the study]: сhange of IL6 after 12 hours from baseline value
IL6 [24 hours from the beginning of the study]: сhange of IL6 after 24 hours from baseline value
IL6 [24 hours from the beginning of the study]: comparison of IL6 after 12 hours with IL6 after 24 hours
SOFA [12 hours from the beginning of the study]: change of SOFA values after 12 hours from baseline value
SOFA [24 hours from the beginning of the study]: change of SOFA values after 24 hours from baseline value
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 outcomes

extracorporeal therapy [hospitalisation period, an average of 1 month]: duration
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
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

+Eligibility

Sex: All, ages: 18 Years to any

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)

+Locations (1)

Facility	City	Country	Status
Petrovsky Nacional research Centre of Surgery	Moscow	Russia	Recruiting

+Investigators

Aleksandr Eremenko, MD, Study director, Petrovsky National Research Centre of Surgery
Tatiana Marchenko, Principal investigator, Petrovsky National Research Centre of Surgery