Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis
Primary Purpose
End Stage Renal Disease (ESRD)
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Acetate by Citrate substitution and vice versa
Sponsored by
About this trial
This is an interventional supportive care trial for End Stage Renal Disease (ESRD)
Eligibility Criteria
Inclusion Criteria:
- time since initiation of dialysis > 3 months
- age > 18 years
- dialysis 3x/week for > 4 hrs
Exclusion Criteria:
- ongoing infection
- pregnancy
- lack of written and informed consent
Sites / Locations
- Nierenzentrum24 NEUPERLACHRecruiting
- Nierenzentrum BogenhausenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Acetate
Citrate
Arm Description
Outcomes
Primary Outcome Measures
Change in Augmentation Index (AIx)
cross over design
Secondary Outcome Measures
Full Information
NCT ID
NCT02745340
First Posted
April 15, 2016
Last Updated
May 3, 2016
Sponsor
Technical University of Munich
Collaborators
Gambro Renal Products, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02745340
Brief Title
Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis
Official Title
Effect of an Acetate-free Dialysis (Citrate Based) on Parameters of Central Hemodynamics, Dialysis Adequacy, Quality of Life and Immunological Parameters in Chronic Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Munich
Collaborators
Gambro Renal Products, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Acetate is the primary acidifying solution used in bicarbonate-based hemodialysis worldwide. It has been published in small trials or case series that the addition of acetate is associated with a rise in nitric oxide production of vascular smooth muscle cells, endothelial cells and myocardial cells as a sign of vascular dysfunction. Furthermore clinical side effects of dialysis e.g. nausea, malnutrition, intradialytic blood pressure drops, induction of proinflammatory cytokines and activation of complement and leukocytes have been described with acetate.
Citrate on the other hand was associated with: Acid-base disorders (metabolic alkalosis), Disturbances of the calcium homeostasis (Hypocalcemia), but also anti-inflammatory effects. Both dialysate additives (citrate and acetate) are commercially available and are used world wide in dialysis centers.
The investigators hypothesize that substitution of acetate by citrate reduces the cardiovascular risk (measured by a change in the surrogate parameter of pulse wave velocity and Augmentation index) and might improves quality of life in the participants. Furthermore the investigators speculate that citrate in the dialysis solution could reduce systemic inflammation in the participants of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease (ESRD)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acetate
Arm Type
Active Comparator
Arm Title
Citrate
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Acetate by Citrate substitution and vice versa
Intervention Description
substitution of acetate by citrate in dialysis fluid
Primary Outcome Measure Information:
Title
Change in Augmentation Index (AIx)
Description
cross over design
Time Frame
6 months (cross over after 3 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
time since initiation of dialysis > 3 months
age > 18 years
dialysis 3x/week for > 4 hrs
Exclusion Criteria:
ongoing infection
pregnancy
lack of written and informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Schmaderer, M.D.
Phone
0049-89-4140
Ext
5053
Email
christoph.schmaderer@mri.tum.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Schmaderer, M.D.
Organizational Affiliation
attending, board certified nephrologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nierenzentrum24 NEUPERLACH
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81737
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Maceiczyk, M.D.
First Name & Middle Initial & Last Name & Degree
Carla Maceizyk, M.D.
Facility Name
Nierenzentrum Bogenhausen
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81925
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Bieber, M.D.
Phone
0049 89 4522380
First Name & Middle Initial & Last Name & Degree
Richard Bieber, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
25791278
Citation
Molina Nunez M, de Alarcon R, Roca S, Alvarez G, Ros MS, Jimeno C, Bucalo L, Villegas I, Garcia MA. Citrate versus acetate-based dialysate in on-line haemodiafiltration. A prospective cross-over study. Blood Purif. 2015;39(1-3):181-187. doi: 10.1159/000371569.
Results Reference
background
Learn more about this trial
Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis
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