NCT05182723

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

February 3, 2022

Status Verified

January 1, 2022

Enrollment Period

3 years

First QC Date

December 1, 2021

Last Update Submit

January 21, 2022

Conditions

Renal Failure AcuteMultiple Organ FailureCardiovascular Diseases

Keywords

mediators of systemic inflammationextracorporeal methodsinterleukins

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (5)

  • extracorporeal therapy

    hospitalisation period, an average of 1 month

  • time spent in intensive care unit

    hospitalisation period, an average of 1 month

  • inpatient stay time

    through study completion, an average of 2 months

  • renal function of RIFLE

    through study completion, an average of 2 months

  • lethality

    through study completion, an average of 2 months

Study Arms (2)

oXiris

ACTIVE COMPARATOR

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

Procedure: renal replacement therapy

oXiris in combination with Jafron HA330

EXPERIMENTAL

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

Interventions

renal replacement therapyPROCEDURE

Extracorporeal Methods for Removing Mediators of Systemic Inflammation

oXirisoXiris in combination with Jafron HA330

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • the impossibility to use heparin ( bleeding; heparin-induced thrombocytopenia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Petrovsky Nacional research Centre of Surgery

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Acute Kidney InjuryMultiple Organ FailureCardiovascular Diseases

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Aleksandr Eremenko, MD

    Petrovsky National Research Centre of Surgery

    STUDY DIRECTOR

  • Tatiana Marchenko

    Petrovsky National Research Centre of Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandr Eremenko, MD

CONTACT

+79037129303aeremenko54@mail.ru

Tatiana Marchenko

CONTACT

+79651077860marta2810@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 1, 2021

First Posted

January 10, 2022

Study Start

November 25, 2021

Primary Completion

November 30, 2024

Study Completion

May 31, 2025

Last Updated

February 3, 2022

Record last verified: 2022-01

Locations

RU(1)