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Completed

NCT Number: NCT05861700

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wieliczko Monika

Warsaw, 01-949, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • stable general condition
  • hemodialysis more than 3 months
  • Dialysis 3 times a week/ 4 hours +/- 20 minutes
  • Dialysis with arterio-venous fistulas
  • bicarbonate titer before hemodialysis 22-24 mmol/l

Exclusion criteria

  • diabetes mellitus
  • cachexia
  • inflamation processes
  • usage of sevelamer last month
  • utrafiltration during dialysis more than 2500 ml

Treatment and study plan

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

Other

A change Dbic in a middle of hemodialysis

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

Other

A change Dbic in a middle of hemodialysis

Primary outcomes

  1. The blood phosphorus concentration change in hemodialysis patient

    Time frame: 4 weeks

    The blood phosphorus concentration change in hemodialysis patient using dialysate bicarbonate profiling

Secondary outcomes

  1. The maintaining the acid-base balance in accordance with applicable recommendations.

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Polish Academy of Sciences
  • University of Warsaw

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
May 17, 2023
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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