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Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis

Effect of an Acetate-free Dialysis (Citrate Based) on Parameters of Central Hemodynamics, Dialysis Adequacy, Quality of Life and Immunological Parameters in Chronic Hemodialysis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02745340
Enrollment
100
Registered
2016-04-20
Start date
2016-05-31
Completion date
2017-04-30
Last updated
2016-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease (ESRD)

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.

Interventions

OTHERAcetate by Citrate substitution and vice versa

substitution of acetate by citrate in dialysis fluid

Sponsors

Gambro Renal Products, Inc.
CollaboratorINDUSTRY
Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Augmentation Index (AIx)6 months (cross over after 3 months)cross over design

Countries

Germany

Contacts

Primary ContactChristoph Schmaderer, M.D.
christoph.schmaderer@mri.tum.de0049-89-4140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026