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RecruitingNCT05182723Updated Feb 3, 2022

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

An interventional study of renal replacement therapy in Renal Failure Acute, Multiple Organ Failure and Cardiovascular Diseases, sponsored by Petrovsky National Research Centre of Surgery. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-03.

Sponsored by Petrovsky National Research Centre of Surgery · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2021; still recruiting 4 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Failure Acute
  • Multiple Organ Failure
  • Cardiovascular Diseases

Keywords

  • mediators of systemic inflammation
  • extracorporeal methods
  • interleukins
03

In context

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Petrovsky National Research Centre of Surgery is the lead sponsor of 18 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • the impossibility to use heparin ( bleeding; heparin-induced thrombocytopenia)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    oXiris

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

    Procedure: renal replacement therapy

  • Experimental
    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.

    Procedure: renal replacement therapy

Interventions

  • Procedurerenal replacement therapy

    Extracorporeal Methods for Removing Mediators of Systemic Inflammation

06

What researchers measure

Primary outcomes

  1. CRP

    сhange of CRP after 12 hours from baseline value

    Time frame: 12 hours from the beginning of the study

  2. CRP

    сhange of CRP after 24 hours from baseline value

    Time frame: 24 hours from the beginning of the study

  3. CRP

    comparison of CRP after 12 hours with CRP after 24 hours

    Time frame: 24 hours from the beginning of the study

  4. IL6

    сhange of IL6 after 12 hours from baseline value

    Time frame: 12 hours from the beginning of the study

  5. IL6

    сhange of IL6 after 24 hours from baseline value

    Time frame: 24 hours from the beginning of the study

  6. IL6

    comparison of IL6 after 12 hours with IL6 after 24 hours

    Time frame: 24 hours from the beginning of the study

  7. SOFA

    change of SOFA values after 12 hours from baseline value

    Time frame: 12 hours from the beginning of the study

  8. SOFA

    change of SOFA values after 24 hours from baseline value

    Time frame: 24 hours from the beginning of the study

  9. SOFA

    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 outcomes

  1. extracorporeal therapy

    duration

    Time frame: hospitalisation period, an average of 1 month

  2. time spent in intensive care unit

    duration

    Time frame: hospitalisation period, an average of 1 month

  3. inpatient stay time

    duration

    Time frame: through study completion, an average of 2 months

  4. renal function of RIFLE

    percentage decrease from initial level

    Time frame: through study completion, an average of 2 months

  5. lethality

    ratio of the number of deaths to the total number of patients

    Time frame: through study completion, an average of 2 months

07

Study locations

1 of 1 sites recruiting
  • Petrovsky Nacional research Centre of Surgery
    Moscow, 119991, Russian Federation
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2021 (actual). Primary completion is estimated for Nov 2024, 36 months after the start.

Of 249 non-industry interventional studies with no phase under Acute Kidney Injury, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 36 months is above that.

Counting every sponsor, half of 267 studies reached it within 26 months; a quarter within 12 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2021
First posted
Jan 10, 2022
StartActual
Nov 25, 2021
Primary completionEst.
Nov 30, 2024
CompletionEst.
May 31, 2025
Last update
Feb 3, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05182723
Lead sponsor
Petrovsky National Research Centre of Surgery
Responsible party
Aleksandr Eremenko (Clinical Professor, Petrovsky National Research Centre of Surgery) — Principal investigator
First posted
Jan 10, 2022
Start date
Nov 25, 2021
Primary completion
Nov 30, 2024 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Feb 3, 2022

Study contacts

Aleksandr Eremenko, MD
Contact
aeremenko54@mail.ru
+79037129303
Tatiana Marchenko
Contact
marta2810@gmail.com
+79651077860
Aleksandr Eremenko, MD
study director · Petrovsky National Research Centre of Surgery
Tatiana Marchenko
principal investigator · Petrovsky National Research Centre of Surgery

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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