Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial
Official title:
Study of Cellulose Triacetate Dialyzer (Solacea™): in Vivo Behavior in Hemodiafiltration-online
Verified date | March 2017 |
Source | Hospital Universitario Infanta Leonor |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 23 |
Est. completion date | August 14, 2016 |
Est. primary completion date | July 10, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion - 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: - pregnancy and illness that would make the patient's death predictable in less than 4 weeks. |
Country | Name | City | State |
---|---|---|---|
Spain | Marta Albalate Ramón | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Infanta Leonor |
Spain,
Maduell F, Navarro V, Hernández-Jaras J, Calvo C. [Comparison of dialyzers in on-line hemodiafiltration]. Nefrologia. 2000 May-Jun;20(3):269-76. Spanish. — View Citation
Mineshima M. Optimal Design of Dialyzers. Contrib Nephrol. 2017;189:204-209. Epub 2016 Dec 12. — View Citation
Sánchez-Villanueva RJ, González E, Quirce S, Díaz R, Alvarez L, Menéndez D, Rodríguez-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. Engl — View Citation
Sunohara T, Masuda T. Cellulose triacetate as a high-performance membrane. Contrib Nephrol. 2011;173:156-63. doi: 10.1159/000329055. Epub 2011 Aug 8. Review. — View Citation
Sunohara T, Masuda T. Fundamental Characteristics of the Newly Developed ATA™ Membrane Dialyzer. Contrib Nephrol. 2017;189:215-221. Epub 2016 Dec 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | One month | |
Primary | Biocompatibility of asymmetric cellulose triacetate (ATA™) | Studying its acute (measuring complement and leukocites) and chronic (measuring monocytes subpopulationsand interleukines) | One month | |
Primary | Clinical behaviour of ATA | Studuying alarm or clínical problemas related with dialyzer | One month |
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