Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change in serum CRP (C-reactive protein)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Single arm
Intervention: Dialysis Solutions (Drug)
Outcomes
Primary Outcomes
Change in serum CRP (C-reactive protein)
Time Frame: Months 4th to 6th
Change in serum CRP during the 3 months of citrate-buffered dialysis
Secondary Outcomes
- Change in dialysis efficiency(Every 3 months (month 0, 6, 3 and completion - 9))
- Change in serum CRP (C-reactive protein)(Every 3 months (month 0, 6, 3 and completion - 9))
Investigators
Vincenzo Cantaluppi
Associate professor of Nephrology
A.O.U. Città della Salute e della Scienza