Renal Failure AcuteNCT05182723
Evaluation of the Effectiveness of Extracorporeal Methods for Removing Mediators of Systemic Inflammation
A study testing renal replacement therapy in people with Renal Failure Acute and Multiple Organ Failure, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure Acute, Multiple Organ Failure, Cardiovascular Diseases
- What is being tested?
- renal replacement therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 25 Nov 2021to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- the impossibility to use heparin ( bleeding; heparin-induced thrombocytopenia)
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Petrovsky Nacional research Centre of Surgery
Moscow, 119991
About this study
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
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.
- Being tested
- renal replacement therapy
- Keywords
- mediators of systemic inflammation, extracorporeal methods, interleukins
- Medical subject headings
- Acute Kidney Injury, Multiple Organ Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal replacement therapyProcedure or surgery
Extracorporeal Methods for Removing Mediators of Systemic Inflammation
| Study group | Role | What they receive |
|---|---|---|
| oXiris | Active comparator | Monotoring of extracorporeal Method for Removing Mediators of Systemic Inflammation of oXiris will be performed for 24 hours Receives: 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. Receives: Procedure: renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP
сhange of CRP after 12 hours from baseline value
Measured: 12 hours from the beginning of the study
CRP
сhange of CRP after 24 hours from baseline value
Measured: 24 hours from the beginning of the study
CRP
comparison of CRP after 12 hours with CRP after 24 hours
Measured: 24 hours from the beginning of the study
IL6
сhange of IL6 after 12 hours from baseline value
Measured: 12 hours from the beginning of the study
IL6
сhange of IL6 after 24 hours from baseline value
Measured: 24 hours from the beginning of the study
IL6
comparison of IL6 after 12 hours with IL6 after 24 hours
Measured: 24 hours from the beginning of the study
SOFA
change of SOFA values after 12 hours from baseline value
Measured: 12 hours from the beginning of the study
SOFA
change of SOFA values after 24 hours from baseline value
Measured: 24 hours from the beginning of the study
SOFA
comparison of the SOFA value after 12 hours with the SOFA value after 24 hours
Measured: 24 hours from the beginning of the study
Secondary outcomes (5)
extracorporeal therapy
duration
Measured: hospitalisation period, an average of 1 month
time spent in intensive care unit
duration
Measured: hospitalisation period, an average of 1 month
inpatient stay time
duration
Measured: through study completion, an average of 2 months
renal function of RIFLE
percentage decrease from initial level
Measured: through study completion, an average of 2 months
lethality
ratio of the number of deaths to the total number of patients
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start25 Nov 2021
- Primary completion30 Nov 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandr Eremenko, Petrovsky National Research Centre of Surgery
- Investigators
- Aleksandr Eremenko, MD, Study director, Petrovsky National Research Centre of SurgeryTatiana Marchenko, Principal investigator, Petrovsky National Research Centre of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182723
- Sponsor's protocol ID
- 20211028-18
- Status last verified
- Jan 2022
- First submitted
- 1 Dec 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05182723
- Acronym / sponsor ID
- 20211028-18
- Keywords
- mediators of systemic inflammation, extracorporeal methods, interleukins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oXiris | Active comparator | Procedure: renal replacement therapyMonotoring of extracorporeal Method for Removing Mediators of Systemic Inflammation of oXiris will be performed for 24 hours |
| oXiris in combination with Jafron HA330 | Experimental | Procedure: renal replacement therapyExtracorporeal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- the impossibility to use heparin ( bleeding; heparin-induced thrombocytopenia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal replacement therapyExtracorporeal Methods for Removing Mediators of Systemic Inflammation | Procedure or surgery | oXiris, oXiris in combination with Jafron HA330 |
Primary outcome
CRP
Time frame: 12 hours from the beginning of the study
сhange of CRP after 12 hours from baseline value
CRP
Time frame: 24 hours from the beginning of the study
сhange of CRP after 24 hours from baseline value
CRP
Time frame: 24 hours from the beginning of the study
comparison of CRP after 12 hours with CRP after 24 hours
IL6
Time frame: 12 hours from the beginning of the study
сhange of IL6 after 12 hours from baseline value
IL6
Time frame: 24 hours from the beginning of the study
сhange of IL6 after 24 hours from baseline value
IL6
Time frame: 24 hours from the beginning of the study
comparison of IL6 after 12 hours with IL6 after 24 hours
SOFA
Time frame: 12 hours from the beginning of the study
change of SOFA values after 12 hours from baseline value
SOFA
Time frame: 24 hours from the beginning of the study
change of SOFA values after 24 hours from baseline value
SOFA
Time frame: 24 hours from the beginning of the study
comparison of the SOFA value after 12 hours with the SOFA value after 24 hours
5 secondary outcomes
extracorporeal therapy
Time frame: hospitalisation period, an average of 1 month
time spent in intensive care unit
Time frame: hospitalisation period, an average of 1 month
inpatient stay time
Time frame: through study completion, an average of 2 months
renal function of RIFLE
Time frame: through study completion, an average of 2 months
lethality
Time frame: through study completion, an average of 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandr Eremenko, MD study director
Petrovsky National Research Centre of Surgery
Tatiana Marchenko principal investigator
Petrovsky National Research Centre of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing renal replacement therapy in people with Renal Failure Acute and Multiple Organ Failure, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksandr Eremenko, MD (+79037129303, aeremenko54@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP (time frame: 12 hours from the beginning of the study). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.