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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.
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
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViE15-A | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Copper/Zinc | In vivo comparison of ROS concentrations in two groups | change from 24 to 72 hours |
| Superoxide Dismutas | In vivo comparison of ROS concentrations in two groups | change from 24 to 72 hours |
| Endogenous peroxidase activity | In vivo comparison of ROS concentrations in two groups | change from 24 to 72 hours |
| Nitric Oxide | In vivo comparison of ROS concentrations in two groups | change from 24 to 72 hours |
| Viability | Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma | change from 24 to 72 hours |
| Apoptosis | Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma | change from 24 to 72 hours |
| Necrosis | Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma | change from 24 to 72 hours |
| Interleukine-6 | In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days |
| Comparison of mechanical Ventilation-free days from enrollment to ICU discharge in two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvia De Rosa, MD | Contact | +393933098583 | derosa.silvia@ymail.com |
| Name | Affiliation | Role |
|---|---|---|
| Claudio Ronco, MD | Department of Nephrology, Dialysis and Transplantation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Bortolo Hospital | Recruiting | Vicenza | 36100 | Italy |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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The randomization list will be kept in a special lockable closet, not accessible to the other investigators involved in the study. The one who will create the list will not be involved in any other role in the present study.
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.
| REXEED-15A | Device | 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. |
|
| change from 24 to 72 hours |
| Interleukine -10 | In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups | change from 24 to 72 hours |
| Interleukine-18 | In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups | change from 24 to 72 hours |
The assessment of the effect of both hemofilters on short term clinical renal outcomes |
| 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 | 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 | 7 days |
| Comparison of renal recovery in two groups | The assessment of the effect of both hemofilters on short term clinical renal outcomes | 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 | 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 | 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 | 90 days |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |