An interventional study of ViE15-A and REXEED-15A in Renal Failure and Renal Insufficiency, Acute, sponsored by St. Bortolo Hospital. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-04.
Sponsored by St. Bortolo Hospital · Not applicable, Interventional, and Health services research
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".
Exclusion Criteria:
The patients were randomly allocated to two groups by using computer-generated numbers. The renal replacement therapy will be started using ViE15-A hemofilter
Device: ViE15-A
TThe patients were randomly allocated to two groups by using computer-generated numbers. The renal replacement therapy will be started using REXEED-15A
Device: 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 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 REXEED-15A.
Copper/Zinc
In vivo comparison of ROS concentrations in two groups
Time frame: change from 24 to 72 hours
Superoxide Dismutas
In vivo comparison of ROS concentrations in two groups
Time frame: change from 24 to 72 hours
Endogenous peroxidase activity
In vivo comparison of ROS concentrations in two groups
Time frame: change from 24 to 72 hours
Nitric Oxide
In vivo comparison of ROS concentrations in two groups
Time frame: change from 24 to 72 hours
Viability
Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma
Time frame: change from 24 to 72 hours
Apoptosis
Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma
Time frame: change from 24 to 72 hours
Necrosis
Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma
Time frame: change from 24 to 72 hours
Interleukine-6
In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups
Time frame: change from 24 to 72 hours
Interleukine -10
In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups
Time frame: change from 24 to 72 hours
Interleukine-18
In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups
Time frame: change from 24 to 72 hours
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 7 days
Comparison of renal recovery in two groups
The assessment of the effect of both hemofilters on short term clinical renal outcomes
Time frame: 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
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
The assessment of the effect of both hemofiltes on long term clinical renal outcomes
Time frame: 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
Time frame: 90 days
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St. Bortolo Hospital