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

Phase 2

Completed

• Conditions: Renal Insufficiency, Chronic; Inflammation
• Interventions: Drug: Dialysis Solutions

• Registration Number: NCT03577249
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-30
• Primary Completion: 2015-07-30
• Study Completion: 2015-07-30
• Study First Submitted: 2018-06-13
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-05
• Last Update Submitted: 2018-07-06
• Last Update Posted: 2018-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single arm	Dialysis Solutions	-

Primary Outcome Measures

Name	Time	Method
Change in serum CRP (C-reactive protein)	Months 4th to 6th	Change in serum CRP during the 3 months of citrate-buffered dialysis

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette; 🇮🇹 Torino, To, Italy