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

Primary Purpose

Renal Failure Acute, Multiple Organ Failure, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
renal replacement therapy
Sponsored by
Petrovsky National Research Centre of Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure Acute focused on measuring mediators of systemic inflammation, extracorporeal methods, interleukins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Petrovsky Nacional research Centre of SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

oXiris

oXiris in combination with Jafron HA330

Arm Description

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

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.

Outcomes

Primary Outcome Measures

CRP
сhange of CRP after 12 hours from baseline value
CRP
сhange of CRP after 24 hours from baseline value
CRP
comparison of CRP after 12 hours with CRP after 24 hours
IL6
сhange of IL6 after 12 hours from baseline value
IL6
сhange of IL6 after 24 hours from baseline value
IL6
comparison of IL6 after 12 hours with IL6 after 24 hours
SOFA
change of SOFA values after 12 hours from baseline value
SOFA
change of SOFA values after 24 hours from baseline value
SOFA
comparison of the SOFA value after 12 hours with the SOFA value after 24 hours

Secondary Outcome Measures

extracorporeal therapy
duration
time spent in intensive care unit
duration
inpatient stay time
duration
renal function of RIFLE
percentage decrease from initial level
lethality
ratio of the number of deaths to the total number of patients

Full Information

First Posted
December 1, 2021
Last Updated
January 21, 2022
Sponsor
Petrovsky National Research Centre of Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT05182723
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Petrovsky National Research Centre of Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Acute, Multiple Organ Failure, Cardiovascular Diseases
Keywords
mediators of systemic inflammation, extracorporeal methods, interleukins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oXiris
Arm Type
Active Comparator
Arm Description
Monotoring of extracorporeal Method for Removing Mediators of Systemic Inflammation of oXiris will be performed for 24 hours
Arm Title
oXiris in combination with Jafron HA330
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
renal replacement therapy
Intervention Description
Extracorporeal Methods for Removing Mediators of Systemic Inflammation
Primary Outcome Measure Information:
Title
CRP
Description
сhange of CRP after 12 hours from baseline value
Time Frame
12 hours from the beginning of the study
Title
CRP
Description
сhange of CRP after 24 hours from baseline value
Time Frame
24 hours from the beginning of the study
Title
CRP
Description
comparison of CRP after 12 hours with CRP after 24 hours
Time Frame
24 hours from the beginning of the study
Title
IL6
Description
сhange of IL6 after 12 hours from baseline value
Time Frame
12 hours from the beginning of the study
Title
IL6
Description
сhange of IL6 after 24 hours from baseline value
Time Frame
24 hours from the beginning of the study
Title
IL6
Description
comparison of IL6 after 12 hours with IL6 after 24 hours
Time Frame
24 hours from the beginning of the study
Title
SOFA
Description
change of SOFA values after 12 hours from baseline value
Time Frame
12 hours from the beginning of the study
Title
SOFA
Description
change of SOFA values after 24 hours from baseline value
Time Frame
24 hours from the beginning of the study
Title
SOFA
Description
comparison of the SOFA value after 12 hours with the SOFA value after 24 hours
Time Frame
24 hours from the beginning of the study
Secondary Outcome Measure Information:
Title
extracorporeal therapy
Description
duration
Time Frame
hospitalisation period, an average of 1 month
Title
time spent in intensive care unit
Description
duration
Time Frame
hospitalisation period, an average of 1 month
Title
inpatient stay time
Description
duration
Time Frame
through study completion, an average of 2 months
Title
renal function of RIFLE
Description
percentage decrease from initial level
Time Frame
through study completion, an average of 2 months
Title
lethality
Description
ratio of the number of deaths to the total number of patients
Time Frame
through study completion, an average of 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandr Eremenko, MD
Phone
+79037129303
Email
aeremenko54@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana Marchenko
Phone
+79651077860
Email
marta2810@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandr Eremenko, MD
Organizational Affiliation
Petrovsky National Research Centre of Surgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tatiana Marchenko
Organizational Affiliation
Petrovsky National Research Centre of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Petrovsky Nacional research Centre of Surgery
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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