Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis

End Stage Renal Disease (ESRD) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02745340
• Other study ID #: 344/15s
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2016
• Last updated: May 3, 2016
• Start date: May 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2016
• Source: Technische Universität München
• Contact: Christoph Schmaderer, M.D.
• Phone: 0049-89-4140
• Email: christoph.schmaderer[@]mri.tum.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• End Stage Renal Disease (ESRD)
• Kidney Failure, Chronic

Intervention

Other:
• Acetate by Citrate substitution and vice versa
substitution of acetate by citrate in dialysis fluid

Locations

Country	Name	City	State
Germany	Nierenzentrum Bogenhausen	Munich	Bavaria
Germany	Nierenzentrum24 NEUPERLACH	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	Gambro Renal Products, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Molina Nuñez M, de Alarcón R, Roca S, Álvarez G, Ros MS, Jimeno C, Bucalo L, Villegas I, García MÁ. Citrate versus acetate-based dialysate in on-line haemodiafiltration. A prospective cross-over study. Blood Purif. 2015;39(1-3):181-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Augmentation Index (AIx)	cross over design	6 months (cross over after 3 months)	No