Inflammation, Renal Insufficiency, Chronic
Conditions
Brief summary
In this study 45 patients undergoing weekly dialysis for chronic end stage renal disease will be enrolled. The patients will be treated with a standard dialysis solution, containing acetate buffer, for 3 months; subsequently the acetate will be substituted with citrate anion for the 3 following months and then, the last 3 months, the standard acetate-solution will be restarted. The aim of the study is to assess if acetate-to-citrate switch in the dialysis solution influences dialysis efficiency and patient inflammatory state.
Interventions
DRUGDialysis Solutions
Solution A: 3mmol/L of acetate anion; Solution B: 1mmol/L of citrate anion
Sponsors
A.O.U. Città della Salute e della Scienza
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
45 patients with end stage renal disease will be treated with dialysis solution A (standard of care: acetate-buffered) for 3 months then with solution B (acetate-free, citrate buffered, otherwise identical to solution A) for 3 months and then with solution A for the final 3 months
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>18 years * creatinine clearance \<5ml/min * treatment with bicarbonate HD (BIC-HD) or on-line hemodiafiltration (OL-HDF) 3 times per week for at least 6 months prior to study start * treated at Dialysis unit of: Città della Salute e della Scienza University Hospital, Torino, Italy
Exclusion criteria
* known neoplastic disease * active chronic inflammatory disease * active acute inflammatory disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum CRP (C-reactive protein) | Months 4th to 6th | Change in serum CRP during the 3 months of citrate-buffered dialysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in dialysis efficiency | Every 3 months (month 0, 6, 3 and completion - 9) | Dougirdas formula will be used to estimate dialysis efficiency at the beginning and completion of each study interval |
| Change in serum CRP (C-reactive protein) | Every 3 months (month 0, 6, 3 and completion - 9) | Variation of serum CRP at the beginning and completion of each study interval |
Countries
Italy
Outcome results
None listed