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Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis

Sponsor
Technische Universität München (Other)
Overall Status
Unknown status
CT.gov ID
NCT02745340
Collaborator
Gambro Renal Products, Inc. (Industry)
100
Enrollment
2
Locations
2
Arms
11
Duration (Months)
50
Patients Per Site
4.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Acetate by Citrate substitution and vice versa
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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 Start Date :
May 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2017
Anticipated Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Acetate

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

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

Outcome Measures

Primary Outcome Measures

  1. Change in Augmentation Index (AIx) [6 months (cross over after 3 months)]

    cross over design

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nierenzentrum24 NEUPERLACH Munich Bavaria Germany 81737
2 Nierenzentrum Bogenhausen Munich Bavaria Germany 81925

Sponsors and Collaborators

  • Technische Universität München
  • Gambro Renal Products, Inc.

Investigators

  • Principal Investigator: Christoph Schmaderer, M.D., attending, board certified nephrologist

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
PD Dr. Christoph Schmaderer, Study Principal Investigator (Prüfer), Technische Universität München
ClinicalTrials.gov Identifier:
NCT02745340
Other Study ID Numbers:
  • 344/15s
First Posted:
Apr 20, 2016
Last Update Posted:
May 4, 2016
Last Verified:
May 1, 2016
Additional relevant MeSH terms:
Kidney Failure, Chronic

Study Results

No Results Posted as of May 4, 2016