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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577249
• Other study ID #: 0064476
• Secondary ID: 2CEI-753
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 30, 2014
• Est. completion date: July 30, 2015

Study information

• Verified date: July 2018
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 30, 2015
• Est. primary completion date: July 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Dialysis Solutions
Solution A: 3mmol/L of acetate anion; Solution B: 1mmol/L of citrate anion

Locations

Country	Name	City	State
Italy	Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette	Torino	To

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum CRP (C-reactive protein)	Change in serum CRP during the 3 months of citrate-buffered dialysis	Months 4th to 6th
Secondary	Change in dialysis efficiency	Dougirdas formula will be used to estimate dialysis efficiency at the beginning and completion of each study interval	Every 3 months (month 0, 6, 3 and completion - 9)
Secondary	Change in serum CRP (C-reactive protein)	Variation of serum CRP at the beginning and completion of each study interval	Every 3 months (month 0, 6, 3 and completion - 9)