Marta Albalate Ramón
Madrid, Spain
NCT Number: NCT03105817
In post-dilution haemodiafiltration only synthetic membranes have been used to date.
The allergy problems described with these membranes require the development of other membranes capable of performing this treatment. We describe in vivo performance and behaviour of an asymmetric cellulose triacetate(ATA™) membrane, to identify its depurative effectiveness and ease of use in clinical practice, as well as evaluate its biocompatibility in a single haemodialysis session (acute biocompatibility) and after one month of treatment (chronic).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Madrid, Spain
An interventional study was performed in 3 hemodialysis hospital units (La Princesa University Hospital, Príncipe de Asturias University Hospital and Infanta Leonor University Hospital, Community of Madrid, Spain) in which the usual dialyzer that each patient had for OLHDF was replaced with the Solacea™ dialyzer keeping the rest of the parameters unchanged. The study (LIB 09/2015) was reviewed and approved by the CEIC of the Príncipe de Asturias University Hospital.
The filtration fraction (FF) was calculated as the percentage of Qi relative to Qb. The convective volume (Vconv) was defined as the total ultra-filtrated volume, which is the sum of VI and UF.7
In CI and CP the following parameters were measured: haemoglobin, proteins and albumin, urea, phosphorus, creatinine, uric acid, β2-microglobulin, myoglobin and retinol transport protein (RTP).
Leukocytes, platelets, C3a and C5a were quantified in CI and CM.
--- Laboratory determinations
For protein bound substances and β2-microglobulin concentrations at the end of the session were corrected for haemoconcentration by a correction factor (FC) based on plasma protein concentration (PT):
FC = PTpre / PTpos, where PTpre and PTpos are the total concentration of proteins pre-dialysis and post-dialysis.
--- Statistical analysis All data was collected in a database (SPSS version 15). Each value was obtained with the average of the values obtained in the different sessions or analytical determinations.
For the statistical analysis, descriptive tools were used, showing the average (standard deviation), median, quartiles or percentages as appropriate. For the comparison of two independent continuous variables, the Student t test for paired samples was used. For the comparison of more than two quantitative variables the ANOVA test was used. The p <0.05 was considered statistically significant.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion
Exclusion criteria
Each patient underwent 12 sessions of haemodialysis with the usual schedule, changing the usual dialyzer
Other names: Solacea™
Time frame: One month
Describing in vivo depurative efficacy of asymmetric cellulose triacetate (ATA™) measuring Kt, infusion volumen and clearance of RR of different molecules
Time frame: One month
Studying its acute (measuring complement and leukocites) and chronic (measuring monocytes subpopulationsand interleukines)
Time frame: One month
Studuying alarm or clínical problemas related with dialyzer
Hospital Universitario Infanta Leonor
Other
Study of Cellulose Triacetate Dialyzer (Solacea™): in Vivo Behavior in Hemodiafiltration-online
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