Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis

NCT ID: NCT02745340

Last Updated: 2016-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-04-30

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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Acetate

Group Type: ACTIVE_COMPARATOR

Acetate by Citrate substitution and vice versa

Intervention Type: OTHER

substitution of acetate by citrate in dialysis fluid

Citrate

Group Type: EXPERIMENTAL

Acetate by Citrate substitution and vice versa

Intervention Type: OTHER

substitution of acetate by citrate in dialysis fluid

Interventions

Acetate by Citrate substitution and vice versa

substitution of acetate by citrate in dialysis fluid

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gambro Renal Products, Inc.

INDUSTRY

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. Christoph Schmaderer

Study Principal Investigator (Prüfer)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph Schmaderer, M.D.

Role: PRINCIPAL_INVESTIGATOR

attending, board certified nephrologist

Locations

Nierenzentrum24 NEUPERLACH

Munich, Bavaria, Germany

Site Status: RECRUITING

Nierenzentrum Bogenhausen

Munich, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Christoph Schmaderer, M.D.

Role: CONTACT

christoph.schmaderer@mri.tum.de

0049-89-4140 ext. 5053

Facility Contacts

Carla Maceiczyk, M.D.

Role: primary

Richard Bieber, M.D.

Role: primary

0049 89 4522380

References

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.

Reference Type: BACKGROUND

PMID: 25791278 (View on PubMed)

Other Identifiers

344/15s

Identifier Type: -

Identifier Source: org_study_id