N/A
N=8
Sodium Chloride and Protein-Bound Toxin Removal in Hemodiafiltration
End-stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01923961 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Removal of Para-cresylsulfate — 42.0; 32.6; 33.6 percentage of reduction
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HDF NaCl (Procedure); Hemodialysis (Procedure); Standard Predilution Hemodiafiltration (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EXcorLab GmbH
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Removal of Para-cresylsulfate |
42.0; 32.6; 33.6 | — |
| PRIMARY Removal of Indoxylsulfate |
34.8; 26.5; 30.9 | — |
| SECONDARY Plasma Sodium Concentrations |
136; 133; 134 | — |
| SECONDARY Hemocompatibility |
0.09; 0.07; 0.08 | — |
Summary
An increase of the free fraction may allow a better removal of of protein-bound uremic toxins during dialysis. During predilution hemodiafiltration, the sodium chloride (NaCl) concentration will be increased in the infusion fluid at a target NaCl concentration and the effect on the removal of protein-bound toxins will be determined. Comparisons will be made to standard hemodialysis and hemodiafiltration.
Eligibility Criteria
Inclusion Criteria
- End-stage renal disease
- Maintenance hemodialysis or hemodiafiltration for more than 3 months
- Stable clinical condition
- > 18 years
Exclusion Criteria
- Life expectancy less than 1 year
- Pregnancy
- Active infectious disease
Data sourced from ClinicalTrials.gov (NCT01923961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.