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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-30

Study Completion Date

2015-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Insufficiency, Chronic Inflammation

Study Design

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Intervention Model

SEQUENTIAL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

Group Type EXPERIMENTAL

Dialysis Solutions

Intervention Type DRUG

Solution A: 3mmol/L of acetate anion; Solution B: 1mmol/L of citrate anion

Interventions

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Dialysis Solutions

Solution A: 3mmol/L of acetate anion; Solution B: 1mmol/L of citrate anion

Intervention Type DRUG

Eligibility Criteria

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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