NCT05861700

The Effect of Bicarbonate Profiling in Dialysis Fluid on Phosphate Removal During Hemodialysis and Blood pH

Completed NA Last updated 23 May 2023

What this trial tests

NA trial testing Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/L in Phosphorus Metabolism Disorders in 20 participants. Completed in 31 August 2022.

Timeline

21 May 2018

Primary endpoint
31 December 2020

31 August 2022

Quick facts

Lead sponsor	Medical University of Warsaw
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	21 May 2018
Primary completion	31 December 2020
Estimated completion	31 August 2022
Sites	1 location across Poland

Drugs / interventions tested

• Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/L
• Group 2: C) Dbic 30 -35 mmol/L B) Dbic 35- 30 mmol/L

Conditions studied

• Phosphorus Metabolism Disorders — all drugs for Phosphorus Metabolism Disorders →
• Acid-Base Balance Disorder — all drugs for Acid-Base Balance Disorder →

Sponsor

Medical University of Warsaw

Who can join

18 and older, any sex, with Phosphorus Metabolism Disorders or Acid-Base Balance Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hyperphosphatemia is still an unresolved problem among hemodialysis patients and significantly increases the risk of death from cardiovascular diseases. Research to date has not answered the question of whether dialysate bicarbonate concentration profiling can improve phosphate removal and its concentration without negative impact on the acid-base balance. This study addressed this issue.

Twenty stable hemodialysis patients will enroll to a four-week study during which different dialysate bicarbonate concentration profiles will be used each week. Each patient will undergo the following profiles (one-week periods): Treatment A - stable dialysate bicarbonate concentration Dbic 35 mmol/L during the whole HD session, Treatment B - Dbic 35 mmol/L for the first two hours and Dbic 30 mmol/L for the next two hours and Treatment C - the opposite mid-HD change Dbic from 30 to 35 mmol/L and one week wash-out period between Treatment B and C. We will collect blood samples each hour during the session and one hour after HD completion.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of time-dependent dialysate bicarbonate concentrations on acid-base and uremic solute kinetics during hemodialysis treatments.
   Wieliczko M, Twardowska-Kawalec M, Debowska M, Pietribiasi M, et al · · 2024 · cited 3× · PMID 38281975 · DOI 10.1038/s41598-024-52757-2