Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation
Primary Purpose
Renal Insufficiency, Chronic, Inflammation
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Dialysis Solutions
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency, Chronic
Eligibility Criteria
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
Sites / Locations
- Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Outcomes
Primary Outcome Measures
Change in serum CRP (C-reactive protein)
Change in serum CRP during the 3 months of citrate-buffered dialysis
Secondary Outcome Measures
Change in dialysis efficiency
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)
Variation of serum CRP at the beginning and completion of each study interval
Full Information
NCT ID
NCT03577249
First Posted
June 13, 2018
Last Updated
July 6, 2018
Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino
1. Study Identification
Unique Protocol Identification Number
NCT03577249
Brief Title
Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation
Official Title
Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 30, 2014 (Actual)
Primary Completion Date
July 30, 2015 (Actual)
Study Completion Date
July 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Model Description
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
Masking
None (Open Label)
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dialysis Solutions
Intervention Description
Solution A: 3mmol/L of acetate anion; Solution B: 1mmol/L of citrate anion
Primary Outcome Measure Information:
Title
Change in serum CRP (C-reactive protein)
Description
Change in serum CRP during the 3 months of citrate-buffered dialysis
Time Frame
Months 4th to 6th
Secondary Outcome Measure Information:
Title
Change in dialysis efficiency
Description
Dougirdas formula will be used to estimate dialysis efficiency at the beginning and completion of each study interval
Time Frame
Every 3 months (month 0, 6, 3 and completion - 9)
Title
Change in serum CRP (C-reactive protein)
Description
Variation of serum CRP at the beginning and completion of each study interval
Time Frame
Every 3 months (month 0, 6, 3 and completion - 9)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette
City
Torino
State/Province
To
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation
We'll reach out to this number within 24 hrs