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

Sponsor

Medical University of Warsaw (Other)

Overall Status

Completed

CT.gov ID

NCT05861700

Collaborator

University of Warsaw (Other), Polish Academy of Sciences (Other)

Enrollment

Location

Arms

51.4

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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

We will collect blood samples each hour during the session and one hour after HD completion.

Condition or Disease	Intervention/Treatment	Phase
Phosphorus Metabolism Disorders Acid-Base Balance Disorder	Other: Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/L Other: Group 2: C) Dbic 30 -35 mmol/L B) Dbic 35- 30 mmol/L	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 21, 2018

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Other: Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/L A change Dbic in a middle of hemodialysis
Active Comparator: 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.	Other: Group 2: C) Dbic 30 -35 mmol/L B) Dbic 35- 30 mmol/L A change Dbic in a middle of hemodialysis

Arm

Intervention/Treatment

Active Comparator: 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.

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

A change Dbic in a middle of hemodialysis

Active Comparator: 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.

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

A change Dbic in a middle of hemodialysis

Outcome Measures

Primary Outcome Measures

The blood phosphorus concentration change in hemodialysis patient [4 weeks]
The blood phosphorus concentration change in hemodialysis patient using dialysate bicarbonate profiling