NCT02745340

Effect of an Acetate-free Dialysis (Citrate Based) on Parameters of Central Hemodynamics, Dialysis Adequacy, Quality of Life and Immunological Parameters in Chronic Hemodialysis

Status unknown NA Last updated 3 May 2016

What this trial tests

NA trial testing Acetate by Citrate substitution and vice versa in End Stage Renal Disease (ESRD) in 100 participants. Status unknown.

Timeline

1 May 2016

Primary endpoint
1 January 2017

1 April 2017

Quick facts

Lead sponsor	Technical University of Munich
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	supportive care
Enrollment	100
Start date	1 May 2016
Primary completion	1 January 2017
Estimated completion	1 April 2017
Sites	2 locations across Germany

Drugs / interventions tested

• Acetate by Citrate substitution and vice versa

Conditions studied

• End Stage Renal Disease (ESRD) — all drugs for End Stage Renal Disease (ESRD) →

Sponsor

Technical University of Munich

Who can join

18 and older, any sex, with End Stage Renal Disease (ESRD). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Augmentation Index (AIx)
  Time frame: 6 months (cross over after 3 months)
  cross over design

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Endothelial dysfunction in retinal vessels of hemodialysis patients compared to healthy controls.
   Günthner R, Lorenz G, Braunisch MC, Angermann S, et al · · 2024 · cited 6× · PMID 38886448 · DOI 10.1038/s41598-024-64581-9
2. Immunophenotypic Characterization of Citrate-Containing A Concentrates in Maintenance Hemodialysis: A Pre-Post Study.
   Shen Y, Schmaderer C, Ossadnik A, Hammitzsch A, et al · · 2023 · cited 2× · PMID 37809041 · DOI 10.1155/2023/7772677
3. Ex Vivo Thrombocyte Function and Its Response to NO/Sildenafil in Patients Undergoing Hemodialysis.
   Bonell V, Schmaderer C, Lorenz G, Günthner R, et al · · 2025 · PMID 40725849 · DOI 10.3390/jcm14145156