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CompletedNCT03105817Updated Apr 10, 2017

Cellulose Triacetate Dialyzer in Hemodiafiltration-online

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

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Feb 2016, registered Mar 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the detailed description

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.

  • Design of the study Each patient underwent 12 sessions of haemodialysis with the usual schedule and monitor: 5008 of Fresenius (n=14), AK200US (n=5) and Artis of Gambro (n=3) and DBB007 of Nikkiso (n=1) all suitable for OLHDF, although with different convective transport control systems. The nursing staff connected the automatic OLHDF system. In the case where the system was Ultracontrol® (Gambro monitors) if alarm of PTM> 300 mmHg or system pressure (PSist)> 700 mmHg appeared and were not solved, Ultracontrol® would be withdrawn and the pressure-control system would be used.
  • Data to be collected:

    1. Demographic and dialysis data

      • Demographic: sex, age, underlying disease, time in OLHDF, type of vascular access: fistula (AFV) and catheter (CT).
      • Dialysis Data: Monitor, dialysis fluid composition, sodium conductivity and bicarbonate concentration, dialysis fluid flow (Qd, ml min), liquid temperature, heparin type and dosage.
      • Each dialysis session: effective time (TE, min), blood flow (Qb, ml min), ultra-filtrated volume to achieve dry weight (UF, l/session), Vinf (l/session), infusion rate, (Qi, ml/min) Kt (l / session), maximum PTM and maximum Psist in Ultracontrol® (mmHg) and the technical complications, alarms and coagulation problems of the system that may appear.

      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

    2. Analytical determinations

      1. Blood

        • On the first and last day of the study pre-dialysis samples were taken for the measurement of monocytes, IL-6 and IL-1β.
        • On the interval day of the first week, 3 blood samples were taken: 1st) at the beginning (CI), 2nd) at 30 min (CM) and the 3rd) at the end of the dialysis session (CP).

        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

        • General biochemical data: haemoglobin, proteins, albumin, urea, phosphorus, reactive protein C (PCR), creatinine and uric acid, β2-microglobulin, myoglobin, and (RTP) were determined with the usual analyser of each hospital.
        • Determinations of monocytes, complement, IL-6 and IL-1β were performed in the laboratory of the University of Alcalá:
        • Activation of plasma complement using a sandwich ELISA: Determination of C3a and C5a activation was performed on platelet rich plasma samples using commercially available ELISA kits C3a Elabscience (Wuhan, P.R. China) and ELISA C5a RayBiotech (Norcross, Georgia).
        • Determination of interleukin concentration in serum using a sandwich ELISA: IL-6 and IL-1β concentrations were measured in serum samples obtained from whole blood and stored at -80 ° C until use. Both kits used were supplied by Abcam (Cambridge, UK)
        • 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.

          • Calculations The percentages of reduction (RR) were calculated with the formula: RR (%) = [(Cpre - Cpos) / Cpre] x 100, where Cpre and Cpos are the concentrations of the analysed substances pre- and post-dialysis.

        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.

02

Conditions studied

  • Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

  • Asymmetric cellulose triacetate
  • Biocompatibility
  • Hemodiafiltration on-line
  • Convective volume
  • Adequacy
03

In context

Kidney Diseases

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 →

Lead sponsor

Hospital Universitario Infanta Leonor is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Criteria:being over 18 years old, being treated with OLHDF for more than 4 weeks with 3 weekly sessions and sign an informed consent form.

Exclusion criteria

Exclusion Criteria:

  • pregnancy and illness that would make the patient's death predictable in less than 4 weeks.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Interventions

  • DeviceAsymmetric cellulose triacetate (ATA™)

    Each patient underwent 12 sessions of haemodialysis with the usual schedule, changing the usual dialyzer

    Also known as: Solacea™

06

What researchers measure

Primary outcomes

  1. 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

  2. Biocompatibility of asymmetric cellulose triacetate (ATA™)

    Studying its acute (measuring complement and leukocites) and chronic (measuring monocytes subpopulationsand interleukines)

    Time frame: One month

  3. Clinical behaviour of ATA

    Studuying alarm or clínical problemas related with dialyzer

    Time frame: One month

07

Study locations

1 site
  • Marta Albalate Ramón
    Madrid, Spain
08

References and documents

Publications

  • Maduell F, Navarro V, Hernandez-Jaras J, Calvo C. [Comparison of dialyzers in on-line hemodiafiltration]. Nefrologia. 2000 May-Jun;20(3):269-76. Spanish. PubMed 10917004 ↗
  • Sunohara T, Masuda T. Fundamental Characteristics of the Newly Developed ATA Membrane Dialyzer. Contrib Nephrol. 2017;189:215-221. doi: 10.1159/000451044. Epub 2016 Dec 12. PubMed 27951571 ↗
  • Sanchez-Villanueva RJ, Gonzalez E, Quirce S, Diaz R, Alvarez L, Menendez D, Rodriguez-Gayo L, Bajo MA, Selgas R. Hypersensitivity reactions to synthetic haemodialysis membranes. Nefrologia. 2014;34(4):520-5. doi: 10.3265/Nefrologia.pre2014.May.12552. English, Spanish. PubMed 25036066 ↗
  • Mineshima M. Optimal Design of Dialyzers. Contrib Nephrol. 2017;189:204-209. doi: 10.1159/000450802. Epub 2016 Dec 12. PubMed 27951569 ↗
  • Sunohara T, Masuda T. Cellulose triacetate as a high-performance membrane. Contrib Nephrol. 2011;173:156-163. doi: 10.1159/000329055. Epub 2011 Aug 8. PubMed 21865788 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03105817
Lead sponsor
Hospital Universitario Infanta Leonor
Responsible party
Sponsor
First posted
Apr 10, 2017
Start date
Feb 1, 2016
Primary completion
Jul 10, 2016
Completion
Aug 14, 2016
Last update
Apr 10, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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