Clinical trial NCT05182723: Evaluation of the Effectiveness of Extracorporeal Methods for Removing Mediators of Systemic Inflammation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Failure Acute
Multiple Organ Failure
Cardiovascular Diseases
Keywords: mediators of systemic inflammation
extracorporeal methods
interleukins
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: CRP
timeFrame: 12 hours from the beginning of the study
measure: CRP
timeFrame: 24 hours from the beginning of the study
measure: CRP
timeFrame: 24 hours from the beginning of the study
measure: IL6
timeFrame: 12 hours from the beginning of the study
measure: IL6
timeFrame: 24 hours from the beginning of the study
measure: IL6
timeFrame: 24 hours from the beginning of the study
measure: SOFA
timeFrame: 12 hours from the beginning of the study
measure: SOFA
timeFrame: 24 hours from the beginning of the study
measure: SOFA
timeFrame: 24 hours from the beginning of the study
Secondary outcomes:
measure: extracorporeal therapy
timeFrame: hospitalisation period, an average of 1 month
measure: time spent in intensive care unit
timeFrame: hospitalisation period, an average of 1 month
measure: inpatient stay time
timeFrame: through study completion, an average of 2 months
measure: renal function of RIFLE
timeFrame: through study completion, an average of 2 months
measure: lethality
timeFrame: through study completion, an average of 2 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Petrovsky Nacional research Centre of Surgery
Study officials:
affiliation: Petrovsky National Research Centre of Surgery
name: Aleksandr Eremenko, MD
role: STUDY_DIRECTOR
affiliation: Petrovsky National Research Centre of Surgery
name: Tatiana Marchenko
role: PRINCIPAL_INVESTIGATOR
References: