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

NCT ID: NCT05182723

Last Updated: 2022-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-25

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Renal Failure Acute Multiple Organ Failure Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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oXiris

Monotoring of extracorporeal Method for Removing Mediators of Systemic Inflammation of oXiris will be performed for 24 hours

Group Type ACTIVE_COMPARATOR

renal replacement therapy

Intervention Type PROCEDURE

Extracorporeal Methods for Removing Mediators of Systemic Inflammation

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.

Group Type EXPERIMENTAL

renal replacement therapy

Intervention Type PROCEDURE

Extracorporeal Methods for Removing Mediators of Systemic Inflammation

Interventions

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renal replacement therapy

Extracorporeal Methods for Removing Mediators of Systemic Inflammation

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Petrovsky National Research Centre of Surgery

OTHER

Sponsor Role lead

Responsible Party

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Aleksandr Eremenko

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aleksandr Eremenko, MD

Role: STUDY_DIRECTOR

Petrovsky National Research Centre of Surgery

Tatiana Marchenko

Role: PRINCIPAL_INVESTIGATOR

Petrovsky National Research Centre of Surgery

Locations

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Petrovsky Nacional research Centre of Surgery

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Aleksandr Eremenko, MD

Role: CONTACT

+79037129303

Tatiana Marchenko

Role: CONTACT

+79651077860

Other Identifiers

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20211028-18

Identifier Type: -

Identifier Source: org_study_id

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