Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis

NCT02745340 | Unknown

• 1 other identifier: 344/15s
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (1)

• Change in Augmentation Index (AIx)

  cross over design

  6 months (cross over after 3 months)

Study Arms (2)

Acetate

ACTIVE COMPARATOR

Other: Acetate by Citrate substitution and vice versa

Citrate

EXPERIMENTAL

Other: Acetate by Citrate substitution and vice versa

Interventions

Acetate by Citrate substitution and vice versa OTHER

substitution of acetate by citrate in dialysis fluid

Acetate; Citrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• time since initiation of dialysis \> 3 months
• age \> 18 years
• dialysis 3x/week for \> 4 hrs

You may not qualify if:

• ongoing infection
• pregnancy
• lack of written and informed consent

Sponsors & Collaborators

• Technical University of Munich: lead
• Gambro Renal Products, Inc.: collaborator

Study Sites (2)

Nierenzentrum24 NEUPERLACH

Munich, Bavaria, 81737, Germany

RECRUITING

Nierenzentrum Bogenhausen

Munich, Bavaria, 81925, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 25791278 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoph Schmaderer, M.D.

  attending, board certified nephrologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Schmaderer, M.D.

CONTACT

0049-89-4140; christoph.schmaderer@mri.tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator (Prüfer)

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 20, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 4, 2016

Record last verified: 2016-05

Locations

DE (2)