Acute Kidney Injury Due to Circulatory Failure (Disorder)EOSIEFNCT04257006
The Effects of Oxiris on Systemic Inflammation and Endothelial dysFunction
A study testing oXiris membrane in people with Acute Kidney Injury Due to Circulatory Failure (Disorder), run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
CS-AKI occurring in 20% to 70% of cases depending of the type of cardiac surgery. The systemic inflammatory response is often observed and associated with increased risk of AKI. Cardiopulmonary bypass (CPB) induces a complex inflammatory response that has a multifactorial pathogenesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury Due to Circulatory Failure (Disorder)
- What is being tested?
- oXiris membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 17 Aug 2020to 1 Jun 2022
- 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
- elective cardiac surgery patients undergoing CPB (>60 minutes) with valve replacement and CABG.
Who cannot join
- Immunosuppressive therapy, CKD 4 and 5 stages, RRT in last 90 days, pregnancy, autoimmune disease, allergy to heparin.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Pavlov First St. Petersburg State Medical University
Saint Petersburg, Russsia, 197022
Yury Polushin, PhD, +78123387823, polushin1@gmail.com
Dmitry Sokolov, MD, +79117193333, sokolovdv82@gmail.com
About this study
Official title: The Effects of oXiris on Systemic Inflammation, Endothelial Dysfunction and Volume Control in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass.
CS-AKI occurring in 20% to 70% of cases depending of the type of cardiac surgery. The systemic inflammatory response is often observed and associated with increased risk of AKI. Cardiopulmonary bypass (CPB) induces a complex inflammatory response that has a multifactorial pathogenesis. The inflammatory response is triggered by exposure of the blood to artificial surfaces during extracorporeal circulation, ischemia/reperfusion injuries, translocation of gram-negative bacteria from the intestinal tract, small amounts of LPS in IV solutions. SIRS during CPB with high levels of inflammatory mediators, active complement proteins and LPS provoke endothelial dysfunction- retraction of endothelial cells with increasing vascular permeability and thrombogenic activity, also inflammatory mediators activate leukocytes and they enhance vascular permeability by affecting endothelial cells and vascular basement membrane. The systemic inflammation and endothelial dysfunction are the basis for multiple organ dysfunction syndrome. Vascular integrity damage during cardiac surgery entail redistribution of fluids with interstitial fluid accumulation and require accurate volume control (pertinent removal of "CPB priming volume"), especially in patients with CKD (low GFR) with high risks of AKI.
Read the detailed description
Specific details of Treatment/Intervention: (prescription and/or therapy, devices, equipment, solutions, product to be used in conducting study:
To apply Prismaflex system with oXiris membrane after cardiopulmonary bypass in SCUF modality for CPB priming volume elimination.
Duration of procedure: 6 hours Blood flow:150-200 ml/min Anticoagulation: no additional heparinization.
According to the features of oXiris membrane:
- Cytokines, complement, endotoxin adsorptive capacity.
- Capability of accurate fluid balance management after cardiac surgery and CPB.
- Reduced demand of anticoagulation therapy for CRRT in patients with high risk of bleeding.
The goal of the research:
- To evaluate effect of adsorption of oXiris membrane on levels of complement (C3a, C5a), pro- and anti-inflammatory cytokines (IL-1β, TNF-α,IL-6,Il-8, IL-10,TGF-β), LPS (EAA levels) after CPB.
- To evaluate leukocytes activation after CPB and after inflammatory mediators adsorption with oXiris (CD11b/CD18)
- To evaluate endothelial dysfunction after CPB and after CRRT with oXiris: endothelial/leukocytes interactions (ICAM-1, VCAM-1), biomarkers of endothelial permeability (angiopoetin-2, sFLT-1), biomarkers of endothelial coagulopathy (von Willebrand factor, thrombomodulin)
- To evaluate effect of volume control with CRRT on CS-AKI and dependence on mechanical ventilation after cardiac surgery, regarding volume overload in patients undergoing CPB with "priming volume" infusion.
- To evaluate stage and topography of cardiac surgery associated acute kidney injury (creatinine, cystatin C, NGAL, KIM-1, β2-microglobuline) in patients in two arms: oXiris and standard protocol.
- To evaluate adsorptive and volume control feasible effects of oXiris membrane on volume management (CVP,PAWP), LPS adsorption, reduction of systemic inflammation , endothelium dysfunction and AKI after cardiac surgery with CPB in comparison with standard protocol.
- Being tested
- oXiris membrane
- Keywords
- acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oXiris membraneDevice
Open heart surgery patients in early postoperative period with clinical signs of fluid overload undergoing CRRT
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing CRRT with oXiris membrane | Experimental | Elective cardiac surgery patients undergoing CPB we will range in 2 groups: I- with Prismaflex set oXiris (SCUF) after CPB, II- standard protocol.
Indications for CRRT (SCUF) with oXiris after ICU admission:
1. Signs of pulmonary edema after cardiac surgery, verified with X-ray control.
Or high risk of pulmonary edema after cardiac surgery:
1. Fluid overload ≥ 10%, measured with equation (%fluid overload= ((total fluid in- total fluid out)/admission body weight*100)
2. CVP (central venous pressure) ˃ 12 mm H2O.
3. PAWP (pulmonary arterial wedge pressure) ˃ 12 mm Hg, measured by Swan-Ganz catheter.
In this arm the treatment of fluid overload will be provided via SCUF with oxiris membrane Receives: Device: oXiris membrane |
| standard protocol | No intervention | Elective cardiac surgery patients undergoing CPB we will range in 2 groups: I- with Prismaflex set oXiris (SCUF) after CPB, II- standard protocol. Indications for CRRT (SCUF) with oXiris after ICU admission: 1. Signs of pulmonary edema after cardiac surgery, verified with X-ray control. Or high risk of pulmonary edema after cardiac surgery: 1. Fluid overload ≥ 10%, measured with equation (%fluid overload= ((total fluid in- total fluid out)/admission body weight*100) 2. CVP (central venous pressure) ˃ 12 mm H2O. 3. PAWP (pulmonary arterial wedge pressure) ˃ 12 mm Hg, measured by Swan-Ganz catheter. In this arm the management of fluid overload will be provided via diuretics or IHD (in condition diuretics treatment resistance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient volume status assessment in perioperative period
To compare volume status in two arms based on CVP mmH2O and PAWP mmHg measurements
Measured: in 24 hours
Secondary outcomes (2)
survival after cardiac surgery
to compare in arms with oxiris treatment and standard protocol amount of survived patients
Measured: in 90 day
'ICU and hospital length of stay after cardiac surgery.
to compare in arms with oxiris treatment and standard protocol the amount of days spent in ICU wards and in hospital
Measured: in 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start17 Aug 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury Due to Circulatory Failure (Disorder)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yury Polushin, PhD, Principal investigator, Pavlov First St. Petersburg State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257006
- Sponsor's protocol ID
- 1BAX-2020
- Acronym
- EOSIEF
- Status last verified
- Aug 2020
- First submitted
- 17 Jan 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified individual participant data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of oXiris on Systemic Inflammation, Endothelial Dysfunction and Volume Control in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass.
- ClinicalTrials.gov ID
- NCT04257006
- Acronym / sponsor ID
- EOSIEF / 1BAX-2020
- Keywords
- acute kidney injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 5 Feb 2020 (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.
CS-AKI occurring in 20% to 70% of cases depending of the type of cardiac surgery. The systemic inflammatory response is often observed and associated with increased risk of AKI. Cardiopulmonary bypass (CPB) induces a complex inflammatory response that has a multifactorial pathogenesis. The inflammatory response is triggered by exposure of the blood to artificial surfaces during extracorporeal circulation, ischemia/reperfusion injuries, translocation of gram-negative bacteria from the intestinal tract, small amounts of LPS in IV solutions. SIRS during CPB with high levels of inflammatory mediators, active complement proteins and LPS provoke endothelial dysfunction- retraction of endothelial cells with increasing vascular permeability and thrombogenic activity, also inflammatory mediators activate leukocytes and they enhance vascular permeability by affecting endothelial cells and vascular basement membrane. The systemic inflammation and endothelial dysfunction are the basis for multiple organ dysfunction syndrome. Vascular integrity damage during cardiac surgery entail redistribution of fluids with interstitial fluid accumulation and require accurate volume control (pertinent removal of "CPB priming volume"), especially in patients with CKD (low GFR) with high risks of AKI.
Detailed description
Specific details of Treatment/Intervention: (prescription and/or therapy, devices, equipment, solutions, product to be used in conducting study:
To apply Prismaflex system with oXiris membrane after cardiopulmonary bypass in SCUF modality for CPB priming volume elimination.
Duration of procedure: 6 hours Blood flow:150-200 ml/min Anticoagulation: no additional heparinization.
According to the features of oXiris membrane:
- Cytokines, complement, endotoxin adsorptive capacity.
- Capability of accurate fluid balance management after cardiac surgery and CPB.
- Reduced demand of anticoagulation therapy for CRRT in patients with high risk of bleeding.
The goal of the research:
- To evaluate effect of adsorption of oXiris membrane on levels of complement (C3a, C5a), pro- and anti-inflammatory cytokines (IL-1β, TNF-α,IL-6,Il-8, IL-10,TGF-β), LPS (EAA levels) after CPB.
- To evaluate leukocytes activation after CPB and after inflammatory mediators adsorption with oXiris (CD11b/CD18)
- To evaluate endothelial dysfunction after CPB and after CRRT with oXiris: endothelial/leukocytes interactions (ICAM-1, VCAM-1), biomarkers of endothelial permeability (angiopoetin-2, sFLT-1), biomarkers of endothelial coagulopathy (von Willebrand factor, thrombomodulin)
- To evaluate effect of volume control with CRRT on CS-AKI and dependence on mechanical ventilation after cardiac surgery, regarding volume overload in patients undergoing CPB with "priming volume" infusion.
- To evaluate stage and topography of cardiac surgery associated acute kidney injury (creatinine, cystatin C, NGAL, KIM-1, β2-microglobuline) in patients in two arms: oXiris and standard protocol.
- To evaluate adsorptive and volume control feasible effects of oXiris membrane on volume management (CVP,PAWP), LPS adsorption, reduction of systemic inflammation , endothelium dysfunction and AKI after cardiac surgery with CPB in comparison with standard protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients undergoing CRRT with oXiris membrane | Experimental | Device: oXiris membraneElective cardiac surgery patients undergoing CPB we will range in 2 groups: I- with Prismaflex set oXiris (SCUF) after CPB, II- standard protocol. Indications for CRRT (SCUF) with oXiris after ICU admission: 1. Signs of pulmonary edema after cardiac surgery, verified with X-ray control. Or high risk of pulmonary edema after cardiac surgery: 1. Fluid overload ≥ 10%, measured with equation (%fluid overload= ((total fluid in- total fluid out)/admission body weight*100) 2. CVP (central venous pressure) ˃ 12 mm H2O. 3. PAWP (pulmonary arterial wedge pressure) ˃ 12 mm Hg, measured by Swan-Ganz catheter. In this arm the treatment of fluid overload will be provided via SCUF with oxiris membrane |
| standard protocol | No intervention | –Elective cardiac surgery patients undergoing CPB we will range in 2 groups: I- with Prismaflex set oXiris (SCUF) after CPB, II- standard protocol. Indications for CRRT (SCUF) with oXiris after ICU admission: 1. Signs of pulmonary edema after cardiac surgery, verified with X-ray control. Or high risk of pulmonary edema after cardiac surgery: 1. Fluid overload ≥ 10%, measured with equation (%fluid overload= ((total fluid in- total fluid out)/admission body weight*100) 2. CVP (central venous pressure) ˃ 12 mm H2O. 3. PAWP (pulmonary arterial wedge pressure) ˃ 12 mm Hg, measured by Swan-Ganz catheter. In this arm the management of fluid overload will be provided via diuretics or IHD (in condition diuretics treatment resistance) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective cardiac surgery patients undergoing CPB (>60 minutes) with valve replacement and CABG.
Key exclusion criteria (1 listed)
- Immunosuppressive therapy, CKD 4 and 5 stages, RRT in last 90 days, pregnancy, autoimmune disease, allergy to heparin.
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 |
|---|---|---|
| oXiris membraneOpen heart surgery patients in early postoperative period with clinical signs of fluid overload undergoing CRRT | Device | patients undergoing CRRT with oXiris membrane |
Primary outcome
Patient volume status assessment in perioperative period
Time frame: in 24 hours
To compare volume status in two arms based on CVP mmH2O and PAWP mmHg measurements
2 secondary outcomes
survival after cardiac surgery
Time frame: in 90 day
'ICU and hospital length of stay after cardiac surgery.
Time frame: in 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: Yes. de-identified individual participant data for all primary and secondary outcome measures will be made available
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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.
Yury Polushin, PhD principal investigator
Pavlov First St. Petersburg State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oXiris membrane in people with Acute Kidney Injury Due to Circulatory Failure (Disorder), run by St. Petersburg State Pavlov Medical University 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 1 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 2 Sep 2020. 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 Yury Polushin, PhD (+7 (812) 338-66-49, polushin1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient volume status assessment in perioperative period (time frame: in 24 hours). 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 2 Sep 2020.