Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Status and phase: Completed; Phase 3; Phase 2

Conditions: Inflammation; Renal Insufficiency, Chronic

Treatments: Drug: Dialysis Solutions

Study type: Interventional

Funder types: Other

Identifiers

NCT03577249

0064476

2CEI-753 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 1 patient group

Single arm

Experimental group

Treatment:

Drug: Dialysis Solutions