An interventional study of VIE A Hemodialyzer and Rexsys 27H hemodialyzer in End Stage Renal Disease and Inflammation, sponsored by Hemotech. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-21.
Sponsored by Hemotech · Not applicable, Interventional, and Treatment
Prospective multicenter randomized cross-over study Number of patients : 32 (8 patients per group) Obtain objectives data to advise each hemodialyzer according to dialysis treatment and patient profile.
To evaluate the different hemodialyzers and judge their extraction performances in HD and post HDF.
Evaluation of the biocompatibility of the hemodialyzers and the patients' inflammatory status.
Medical devices studied :
These hemodialyzers are EC marked and are used in their own indications.
Schema
Details of the cross-over plan :
8 patients will be treated successively with the 4 hemodialyzers. Patients will be treated with the dialyzer "test" for the two first sessions of the week. During the last dialysis session of each week, only their usual dialyzer will be used as wash-out. A randomization will define the order of use of the dialyzers in the 4 centers. This order will be identical in a center.
Number of patients :
32 (8 patients per center (4 centers))
Duration :
One week per dialyzer
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 32 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Hemotech is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
patients treated by conventionnal hemodialysis
Device: VIE A Hemodialyzer · Device: Rexsys 27H hemodialyzer · Device: Leoceed 21HX hemodialyzer · Device: Polypure 22S+ hemodialyzer
patients treated by HDF post-dilution
Device: VIE A Hemodialyzer · Device: Rexsys 27H hemodialyzer · Device: Leoceed 21HX hemodialyzer · Device: Polypure 22S+ hemodialyzer
polysulfon membrane coated with vitamin E
polyethersulfon membrane with large surface area : 2,7m²
polyslfon membrane with gamma sterilization
polysulfon membrane with steam sterilization
Evaluation of middle molecules extraction
Measurements of β 2 microglobulin (11,8kDa), myoglobin (17kDa), Beta Trace (21kDa), Free immunoglobulin light chains Kappa (23kDa), myostatin (40kDa), glycoprotein orosomucoïd (44kDa)
Time frame: one week per dialyzer per patient
Extraction of uremic toxins
* Urea * Creatinin * inorganic phosphates
Time frame: one week per dialyzer per patient
Biocompatibility assessment
* Anaphylatoxins (C3a, C5a) during the session (T0, T15, Tend) * TNF-α and IL-6 (T0 et Tend)
Time frame: one week per dialyzer per patient
Monitoring of Nutrition status
Quantification of the albumin loss in the used dialysate (1 center) during the middle session of the week for each dialyzer tested per patient, i.e 4 times/patient. 2 analysis modalities will be used: " pull and push " syringe Plastipak BD 50mL or collection of the whole dialysate in a 200 L tank Dosage Albumin et pre-albumin before dialysis session
Time frame: one week per dialyzer per patient
Handling of the devices
- Evaluation of the priming and recovery for each dialysis session
Time frame: one week per dialyzer per patient
Dialysis adequacy evaluation
Calculation of KT/V
Time frame: one week per dialyzer per patient
Session tolerance
All secondary troubles will be noted: cramps, nauseas, hypotension...
Time frame: one week per dialyzer per patient
Parameters inflammation
CRP (mg/l)
Time frame: one week per dialyzer per patient
Parameters inflammation
- Calcul of PINI = \[CRP(mg/l) x Orosomucoïd (mg/l)\] / \[Albumin(g/l) x Pre-albumin(mg/l)\]
Time frame: one week per dialyzer per patient
Plan to share: No
Ran from Nov 2016 to primary completion in Jul 2018, 20 months.
Of 78 industry-sponsored interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 40. This study's 20 months is above that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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