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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2022-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Phosphorus Metabolism Disorders Acid-Base Balance Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Week 1 - a constant Dbic 35 mmol/L -Treatment A. Week 2 - Dbic 35 mmol/L for the first two hours followed by 30 mmol/L for the remainder of the treatment- Treatment B.

Week 3 - a constant Dbic 35 mmol/L (wash-out period). Week 4 - Dbic 30 mmol/L for the first two hours followed by 35 mmol/L for the remainder of the treatment -Treatment C.

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

A change Dbic in a middle of hemodialysis

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

Week 1 - a constant Dbic 35 mmol/L -Treatment A. Week 2 - Dbic 30 mmol/L for the first two hours followed by 35 mmol/L for the remainder of the treatment- Treatment C.

Week 3 - a constant Dbic 35 mmol/L (wash-out period). Week 4 - Dbic 35 mmol/L for the first two hours followed by 30 mmol/L for the remainder of the treatment -Treatment B.

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

A change Dbic in a middle of hemodialysis

Interventions

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

A change Dbic in a middle of hemodialysis

Intervention Type OTHER

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

A change Dbic in a middle of hemodialysis

Intervention Type OTHER

Eligibility Criteria

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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