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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05861700
Enrollment
20
Registered
2023-05-17
Start date
2018-05-21
Completion date
2022-08-31
Last updated
2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acid-Base Balance Disorder, Phosphorus Metabolism Disorders

Keywords

phosphorus, hemodialysis, bicarbonate, acidosis, alkalosis

Brief summary

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.

Interventions

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

A change Dbic in a middle of hemodialysis

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

A change Dbic in a middle of hemodialysis

Sponsors

University of Warsaw
CollaboratorOTHER
Polish Academy of Sciences
CollaboratorOTHER
Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Blood acid-base and uremic solute levels were measured in twenty chronic HD patients during 4-hour treatments with A) constant Dbic of 35 mmol/L; B) Dbic of 35 mmol/L for the first two hours and 30 mmol/L for the second two hours; and C) Dbic of 30 mmol/L for the first 2 hours and 35 mmol/L later. Treatment interventions were fixed during a given week, arterial blood samples were obtained predialysis and every hour during the treatment, during the second and third treatments of the week.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The blood phosphorus concentration change in hemodialysis patient4 weeksThe blood phosphorus concentration change in hemodialysis patient using dialysate bicarbonate profiling

Secondary

MeasureTime frame
The maintaining the acid-base balance in accordance with applicable recommendations.4 weeks

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026