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.

Study Overview

• Status: Completed
• Conditions: Phosphorus Metabolism Disorders; Acid-Base Balance Disorder
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-949
    • Wieliczko Monika

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The blood phosphorus concentration change in hemodialysis patient	The blood phosphorus concentration change in hemodialysis patient using dialysate bicarbonate profiling	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The maintaining the acid-base balance in accordance with applicable recommendations.	4 weeks

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Collaborators: Polish Academy of Sciences; University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: May 6, 2023
• First Submitted That Met QC Criteria: May 6, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 21, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: hemodialysis; phosphorus; acidosis; bicarbonate; alkalosis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Metabolic Diseases; Phosphorus Metabolism Disorders
• Other Study ID Numbers: KB/91/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No