Inflammation Clinical Trial
Official title:
Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation
Verified date | July 2018 |
Source | Azienda Ospedaliera Città della Salute e della Scienza di Torino |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | July 30, 2015 |
Est. primary completion date | July 30, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette | Torino | To |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Città della Salute e della Scienza di Torino |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in serum CRP (C-reactive protein) | Change in serum CRP during the 3 months of citrate-buffered dialysis | Months 4th to 6th | |
Secondary | Change in dialysis efficiency | Dougirdas formula will be used to estimate dialysis efficiency at the beginning and completion of each study interval | Every 3 months (month 0, 6, 3 and completion - 9) | |
Secondary | Change in serum CRP (C-reactive protein) | Variation of serum CRP at the beginning and completion of each study interval | Every 3 months (month 0, 6, 3 and completion - 9) |
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