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Completed

NCT Number: NCT03577249

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

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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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette

Torino, To, 10126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialysis Solutions

Drug

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

Primary outcomes

  1. 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

  1. Change in dialysis efficiency

    Time frame: 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

  2. Change in serum CRP (C-reactive protein)

    Time frame: Every 3 months (month 0, 6, 3 and completion - 9)

    Variation of serum CRP at the beginning and completion of each study interval

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 5, 2018
Registry last updated
Jul 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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