Renal FailureVitabrane ENCT03489759
The Effect of Vitamin E-coated Polysulfone Membrane on Oxidative Stress, Inflammation and Monocytes in Critically Ill Patients in CRRT
A study testing ViE15-A and REXEED-15A in people with Renal Failure and Renal Insufficiency, Acute, run by St. Bortolo Hospital at 1 site in Italy.
Trial summary
The study evaluate the effect of a membrane in polysulfone covered with vitamin E (ViE15-A, ASAHI Kasey, Tokyo, Japan) versus non-vitamin E polysulfone membrane (REXEED-15A, ASAHI Kasey, Tokyo, Japan) in critically ill patients admitted to intensive care undergoing continuous extracorporeal dialysis (CRRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Renal Insufficiency, Acute
- What is being tested?
- ViE15-A and REXEED-15A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 13 Mar 2018to 13 Dec 2019
- 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
- Age > 18 years
- Acute Kidney Injury
- ICU patients with clinical indication for Continuous Renal Replacement Therapy
- Clinical decision to begin CVVH for at least 24 hours with high flux filter (defined as membranes with an ultrafiltration coefficient KUF > 25ml/Kg/h)
- Obtain the informed consent
Who cannot join
- Hemodialysis patients, peritoneal dialysis patients and transplant recipient;
- Hypothermia (T < 36°C)
- Regional Anticoagulation with Citrate
- Septic Shock;
- Neoplasm in Chemotherapy
- Extra-Corporeal Membrane Oxygenation
Show all 11Show fewer
- Cardio Circulatory Arrest
- Autoimmune disease or immunosuppressed patients;
- Life expectancy < 24 hr
- Pregnancy;
- Informed Consent refused by the patient or surrogate decision-maker
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Bortolo Hospital
Vicenza, 36100
Silvia De Rosa, MD, derosa.silvia@ymail.com
About this study
Official title: The Effect of Vitamin E-coated Polysulfone Membrane on Oxidative Stress, Inflammation and Monocytes in Critically Ill Patients in CRRT: a Pilot, Randomized, Double-blinded, No-profit, Clinical Study
The study evaluate the effect of a membrane in polysulfone covered with vitamin E (ViE15-A, ASAHI Kasey, Tokyo, Japan) versus non-vitamin E polysulfone membrane (REXEED-15A, ASAHI Kasey, Tokyo, Japan) in critically ill patients admitted to intensive care undergoing continuous extracorporeal dialysis (CRRT).
The current randomized study is designed to assess the effect on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines using ViE 15-A in comparison withe REXEED-15A.
The investigators hypothezise that the ViE15-A versus REXEED-15A will have different effect on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines.
Read the detailed description
The study evaluate the effect of a membrane in polysulfone covered with vitamin E (ViE15-A, ASAHI Kasey, Tokyo, Japan) on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines in critically ill patients admitted to intensive care undergoing continuous extracorporeal dialysis (CRRT).
This membrane will be compared with a non-vitamin E polysulfone membrane (REXEED-15A, ASAHI Kasey, Tokyo, Japan) and already intended for use in continuous renal support therapy.
The current randomized study is designed to assess the effect on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines using ViE 15-A in comparison withe REXEED-15A.
Precisely, will be evaluated
- the effect of the filter on the reduction of the plasma levels of two pro-inflammatory cytokines (IL-1β and IL-6) and of two anti-inflammatory cytokines (IL-10, IL-8);
- the analysis of the life modality of the monocytic cells: the patient's plasma will be used, incubated for 24 hours with U937 cells (monocyte precursor cells), necrosis cells and the percentage of apoptotic cells. The apoptotic cells will also evaluate the apoptotic pathway (evaluation of activated caspases) that led to cell death. The differences that are highlighted in the two different sampling moments become expressed Δ% with respect to the initial value Secondary outcomes will be to evaluate the clinical outcomes (haemodynamic and hematochemical parameters) in the short and long term deriving from the application of a membrane with vitamin E; for this reason, for the whole duration of the extracorporeal dialysis therapy, the same filter assigned to the patient at the time of enrollment will be used.
All the other parameters of the extracorporeal treatment that can influence the results will be standardized; in particular, the flows will be fixed according to the dialysis dose criteria and re-infusion methods according to the table in the paragraph "treatment characteristics".
- Conditions
- Renal Failure, Renal Insufficiency, Acute
- Being tested
- ViE15-A, REXEED-15A
- Keywords
- Acute Kidney Injury, Oxidative Stress, Renal Replacement Therapy, Vitamine E-coated Polysulfone Membrane
- Medical subject headings
- Renal Insufficiency, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViE15-ADevice
The type of dialytic treatment that will be used during the study will be continuous venous hemofiltration (CVVH-Continuous veno-venous hemofiltration). The filter will be ViE15-A.
REXEED-15ADevice
The type of dialytic treatment that will be used during the study will be continuous venous hemofiltration (CVVH-Continuous veno-venous hemofiltration). The filter will be REXEED-15A.
| Study group | Role | What they receive |
|---|---|---|
| ViE15-A | Experimental | The patients were randomly allocated to two groups by using computer-generated numbers. The renal replacement therapy will be started using ViE15-A hemofilter Receives: Device: ViE15-A |
| REXEED-15A | Active comparator | TThe patients were randomly allocated to two groups by using computer-generated numbers. The renal replacement therapy will be started using REXEED-15A Receives: Device: REXEED-15A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Copper/Zinc
In vivo comparison of ROS concentrations in two groups
Measured: change from 24 to 72 hours
Superoxide Dismutas
In vivo comparison of ROS concentrations in two groups
Measured: change from 24 to 72 hours
Endogenous peroxidase activity
In vivo comparison of ROS concentrations in two groups
Measured: change from 24 to 72 hours
Nitric Oxide
In vivo comparison of ROS concentrations in two groups
Measured: change from 24 to 72 hours
Viability
Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma
Measured: change from 24 to 72 hours
Apoptosis
Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma
Measured: change from 24 to 72 hours
Necrosis
Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma
Measured: change from 24 to 72 hours
Interleukine-6
In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups
Measured: change from 24 to 72 hours
Interleukine -10
In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups
Measured: change from 24 to 72 hours
Interleukine-18
In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups
Measured: change from 24 to 72 hours
Secondary outcomes (8)
Comparison of CRRT-free days from enrollment to ICU discharge in two groups
The assessment of the effect of both hemofilters on short term clinical renal outcomes
Measured: 7 days
Comparison of mechanical Ventilation-free days from enrollment to ICU discharge in two groups
The assessment of the effect of both hemofilters on short term clinical renal outcomes
Measured: 7 days
Comparison of vasopressor drugs-free days in two groups
The assessment of the effect of both hemofilters on short term clinical renal outcomes
Measured: 7 days
Comparison of ICU length of stay in two groups
The assessment of the effect of both hemofilters on short term clinical renal outcomes
Measured: 7 days
Comparison of renal recovery in two groups
The assessment of the effect of both hemofilters on short term clinical renal outcomes
Measured: 7 days
Comparison of CRRT-free days from enrollment to hospital discharge in two groups
The assessment of the effect of both hemofiltes on long term clinical renal outcomes
Measured: 90 days
Comparison of need of (Intermittent Hemodialysis) IHD at hospital discarge in patients treated with vitamine E-coated membrane and non-vitamin E-coated membrane
The assessment of the effect of both hemofiltes on long term clinical renal outcomes
Measured: 90 days
Comparison of renal recovery at hospital discharge in two groups
The assessment of the effect of both hemofiltes on long term clinical renal outcomes
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start13 Mar 2018
- Primary completion13 Sep 2018
- Study completion13 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Bortolo Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia De Rosa, St. Bortolo Hospital
- Investigators
- Claudio Ronco, MD, Study director, Department of Nephrology, Dialysis and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489759
- Sponsor's protocol ID
- 79/16A
- Acronym
- Vitabrane E
- Status last verified
- Apr 2019
- First submitted
- 13 Mar 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin E-coated Polysulfone Membrane on Oxidative Stress, Inflammation and Monocytes in Critically Ill Patients in CRRT: a Pilot, Randomized, Double-blinded, No-profit, Clinical Study
- ClinicalTrials.gov ID
- NCT03489759
- Acronym / sponsor ID
- Vitabrane E / 79/16A
- Conditions
- Renal Failure, Renal Insufficiency, Acute
- Keywords
- Acute Kidney Injury, Oxidative Stress, Renal Replacement Therapy, Vitamine E-coated Polysulfone Membrane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- St. Bortolo HospitalUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 13 Dec 2019 (estimated)
- First posted
- 5 Apr 2018 (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 study evaluate the effect of a membrane in polysulfone covered with vitamin E (ViE15-A, ASAHI Kasey, Tokyo, Japan) versus non-vitamin E polysulfone membrane (REXEED-15A, ASAHI Kasey, Tokyo, Japan) in critically ill patients admitted to intensive care undergoing continuous extracorporeal dialysis (CRRT).
The current randomized study is designed to assess the effect on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines using ViE 15-A in comparison withe REXEED-15A.
The investigators hypothezise that the ViE15-A versus REXEED-15A will have different effect on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines.
Detailed description
The study evaluate the effect of a membrane in polysulfone covered with vitamin E (ViE15-A, ASAHI Kasey, Tokyo, Japan) on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines in critically ill patients admitted to intensive care undergoing continuous extracorporeal dialysis (CRRT).
This membrane will be compared with a non-vitamin E polysulfone membrane (REXEED-15A, ASAHI Kasey, Tokyo, Japan) and already intended for use in continuous renal support therapy.
The current randomized study is designed to assess the effect on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines using ViE 15-A in comparison withe REXEED-15A.
Precisely, will be evaluated
- the effect of the filter on the reduction of the plasma levels of two pro-inflammatory cytokines (IL-1β and IL-6) and of two anti-inflammatory cytokines (IL-10, IL-8);
- the analysis of the life modality of the monocytic cells: the patient's plasma will be used, incubated for 24 hours with U937 cells (monocyte precursor cells), necrosis cells and the percentage of apoptotic cells. The apoptotic cells will also evaluate the apoptotic pathway (evaluation of activated caspases) that led to cell death. The differences that are highlighted in the two different sampling moments become expressed Δ% with respect to the initial value Secondary outcomes will be to evaluate the clinical outcomes (haemodynamic and hematochemical parameters) in the short and long term deriving from the application of a membrane with vitamin E; for this reason, for the whole duration of the extracorporeal dialysis therapy, the same filter assigned to the patient at the time of enrollment will be used.
All the other parameters of the extracorporeal treatment that can influence the results will be standardized; in particular, the flows will be fixed according to the dialysis dose criteria and re-infusion methods according to the table in the paragraph "treatment characteristics".
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ViE15-A | Experimental | Device: ViE15-AThe patients were randomly allocated to two groups by using computer-generated numbers. The renal replacement therapy will be started using ViE15-A hemofilter |
| REXEED-15A | Active comparator | Device: REXEED-15ATThe patients were randomly allocated to two groups by using computer-generated numbers. The renal replacement therapy will be started using REXEED-15A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Acute Kidney Injury
- ICU patients with clinical indication for Continuous Renal Replacement Therapy
- Clinical decision to begin CVVH for at least 24 hours with high flux filter (defined as membranes with an ultrafiltration coefficient KUF > 25ml/Kg/h)
- Obtain the informed consent
Key exclusion criteria (11 listed)
- Hemodialysis patients, peritoneal dialysis patients and transplant recipient;
- Hypothermia (T < 36°C)
- Regional Anticoagulation with Citrate
- Septic Shock;
- Neoplasm in Chemotherapy
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 |
|---|---|---|
| ViE15-AThe type of dialytic treatment that will be used during the study will be continuous venous hemofiltration (CVVH-Continuous veno-venous hemofiltration). The filter will be ViE15-A. | Device | ViE15-A |
| REXEED-15AThe type of dialytic treatment that will be used during the study will be continuous venous hemofiltration (CVVH-Continuous veno-venous hemofiltration). The filter will be REXEED-15A. | Device | REXEED-15A |
Primary outcome
Copper/Zinc
Time frame: change from 24 to 72 hours
In vivo comparison of ROS concentrations in two groups
Superoxide Dismutas
Time frame: change from 24 to 72 hours
In vivo comparison of ROS concentrations in two groups
Endogenous peroxidase activity
Time frame: change from 24 to 72 hours
In vivo comparison of ROS concentrations in two groups
Nitric Oxide
Time frame: change from 24 to 72 hours
In vivo comparison of ROS concentrations in two groups
Viability
Time frame: change from 24 to 72 hours
Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma
Apoptosis
Time frame: change from 24 to 72 hours
Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma
Necrosis
Time frame: change from 24 to 72 hours
Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma
Interleukine-6
Time frame: change from 24 to 72 hours
In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups
Interleukine -10
Time frame: change from 24 to 72 hours
In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups
Interleukine-18
Time frame: change from 24 to 72 hours
In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups
8 secondary outcomes
Comparison of CRRT-free days from enrollment to ICU discharge in two groups
Time frame: 7 days
Comparison of mechanical Ventilation-free days from enrollment to ICU discharge in two groups
Time frame: 7 days
Comparison of vasopressor drugs-free days in two groups
Time frame: 7 days
Comparison of ICU length of stay in two groups
Time frame: 7 days
Comparison of renal recovery in two groups
Time frame: 7 days
Comparison of CRRT-free days from enrollment to hospital discharge in two groups
Time frame: 90 days
Comparison of need of (Intermittent Hemodialysis) IHD at hospital discarge in patients treated with vitamine E-coated membrane and non-vitamin E-coated membrane
Time frame: 90 days
Comparison of renal recovery at hospital discharge in two groups
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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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.
Claudio Ronco, MD study director
Department of Nephrology, Dialysis and Transplantation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ViE15-A and REXEED-15A in people with Renal Failure and Renal Insufficiency, Acute, run by St. Bortolo Hospital at 1 site in Italy.
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 5 inclusion and 11 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 4 Apr 2019. 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 Italy. 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 Silvia De Rosa, MD (+393933098583, derosa.silvia@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Copper/Zinc (time frame: change from 24 to 72 hours). The study lists 10 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 4 Apr 2019.