The Effect of Vitamin E-coated Polysulfone Membrane on Oxidative Stress, Inflammation and Monocytes in Critically Ill Patients in CRRT
NCT ID: NCT03489759
Last Updated: 2019-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-03-13
2019-12-13
Brief Summary
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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.
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Detailed Description
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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
1. 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);
2. 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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
QUADRUPLE
The filter label, and hence the name, will be covered by a white covering label. Each kit of filters needed to perform a single treatment will be prepared in a closed box and the patient number will be written on it, so that the user who performs the treatment will not be able to understand which filter it is.
All the other investigators involved in the present study (nurses in the Nephrology department who will follow the treatment, the researchers who will collect the clinical data, the biologists who will analyze the samples and the statisticians who will analyze the data) will not know which filter has been applied in each treatment.
Study Groups
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ViE15-A
The patients were randomly allocated to two groups by using computer-generated numbers. The renal replacement therapy will be started using ViE15-A hemofilter
ViE15-A
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-15A
TThe patients were randomly allocated to two groups by using computer-generated numbers. The renal replacement therapy will be started using REXEED-15A
REXEED-15A
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.
Interventions
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ViE15-A
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-15A
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Hypothermia (T \< 36°C)
* Regional Anticoagulation with Citrate
* Septic Shock;
* Neoplasm in Chemotherapy
* Extra-Corporeal Membrane Oxygenation
* Cardio Circulatory Arrest
* Autoimmune disease or immunosuppressed patients;
* Life expectancy \< 24 hr
* Pregnancy;
* Informed Consent refused by the patient or surrogate decision-maker
18 Years
ALL
No
Sponsors
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St. Bortolo Hospital
OTHER
Responsible Party
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Silvia De Rosa
Medical Doctor
Principal Investigators
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Claudio Ronco, MD
Role: STUDY_DIRECTOR
Department of Nephrology, Dialysis and Transplantation
Locations
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San Bortolo Hospital
Vicenza, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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79/16A
Identifier Type: -
Identifier Source: org_study_id
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