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Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis

NCT02745340 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-05-04

No results posted yet for this study

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)

Interventions

OTHER

Acetate by Citrate substitution and vice versa

substitution of acetate by citrate in dialysis fluid

Sponsors & Collaborators

  • Gambro Renal Products, Inc.

    collaborator INDUSTRY

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Christoph Schmaderer, M.D. · attending, board certified nephrologist

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-01-31
Completion
2017-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02745340 on ClinicalTrials.gov