Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis

Not Applicable

• Conditions: End Stage Renal Disease (ESRD)
• Interventions: Other: Acetate by Citrate substitution and vice versa

• Registration Number: NCT02745340
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-20
• Status Verified: 2016-05
• Study Start: 2016-05
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-04
• Primary Completion: 2017-01
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acetate	Acetate by Citrate substitution and vice versa	-
Citrate	Acetate by Citrate substitution and vice versa	-

Primary Outcome Measures

Name	Time	Method
Change in Augmentation Index (AIx)	6 months (cross over after 3 months)	cross over design

Trial Locations

Locations (2)

Nierenzentrum Bogenhausen; 🇩🇪 Munich, Bavaria, Germany

Nierenzentrum24 NEUPERLACH; 🇩🇪 Munich, Bavaria, Germany