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

Primary Purpose

Phosphorus Metabolism Disorders, Acid-Base Balance Disorder

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
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
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phosphorus Metabolism Disorders focused on measuring phosphorus, hemodialysis, bicarbonate, acidosis, alkalosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wieliczko Monika

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2023
Last Updated
May 21, 2023
Sponsor
Medical University of Warsaw
Collaborators
University of Warsaw, Polish Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05861700
Brief Title
The Effect of Bicarbonate Profiling in Dialysis Fluid on Phosphate Removal During Hemodialysis and Blood pH
Official Title
The Effect of Bicarbonate Profiling in Dialysis Fluid on Phosphate Removal During Hemodialysis and Blood pH
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
Collaborators
University of Warsaw, Polish Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phosphorus Metabolism Disorders, Acid-Base Balance Disorder
Keywords
phosphorus, hemodialysis, bicarbonate, acidosis, alkalosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/L
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2: C) Dbic 30- 35 mmol/L B) Dbic 35 -30 mmol/L
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/L
Intervention Description
A change Dbic in a middle of hemodialysis
Intervention Type
Other
Intervention Name(s)
Group 2: C) Dbic 30 -35 mmol/L B) Dbic 35- 30 mmol/L
Intervention Description
A change Dbic in a middle of hemodialysis
Primary Outcome Measure Information:
Title
The blood phosphorus concentration change in hemodialysis patient
Description
The blood phosphorus concentration change in hemodialysis patient using dialysate bicarbonate profiling
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The maintaining the acid-base balance in accordance with applicable recommendations.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Wieliczko Monika
City
Warsaw
ZIP/Postal Code
01-949
Country
Poland

12. IPD Sharing Statement

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

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