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".
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →St. Bortolo Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.
Compared within Acute Kidney Injury, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Renal Insufficiency. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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St. Bortolo Hospital