An interventional study of Asymmetric cellulose triacetate (ATA™) in Chronic Kidney Disease Requiring Chronic Dialysis, sponsored by Hospital Universitario Infanta Leonor. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-10.
Sponsored by Hospital Universitario Infanta Leonor · Not applicable, Interventional, and Treatment
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).
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.
Data to be collected:
Demographic and dialysis data
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
Analytical determinations
Blood
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
Determination of monocyte subpopulations: The different subpopulations of circulating monocytes in peripheral blood were identified by flow cytometry (FACSCalibur™, Becton Dickinson, San Jose, CA, USA). First of all, the monocyte population was selected according to size (FSC/forward scatter) and granularity (SSC/side scatter) and then the different subpopulations were selected by double immunofluorescence according to staining with the anti-CD14 conjugated Tricolor (monoclonal antibodies TuK4) and anti-CD16 conjugated FITC (monoclonal antibodies 3G8). Both antibodies and their respective isotype controls were purchased from Life Technologies Invitrogen (California, USA). The analysis was performed with the Cyflogic program.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 23 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Hospital Universitario Infanta Leonor is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Each patient underwent 12 sessions of haemodialysis with the usual schedule, changing the usual dialyzer
Also known as: Solacea™
Performance of asymmetric cellulose triacetate (ATA™)
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
Biocompatibility of asymmetric cellulose triacetate (ATA™)
Studying its acute (measuring complement and leukocites) and chronic (measuring monocytes subpopulationsand interleukines)
Time frame: One month
Clinical behaviour of ATA
Studuying alarm or clínical problemas related with dialyzer
Time frame: One month
Plan to share: No
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Infanta Leonor