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

Acid-Base Balance Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05861700
• Other study ID #: KB/91/2018
• Status: Completed
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: August 31, 2022

Study information

• Verified date: May 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acid-Base Balance Disorder
• Disease
• Metabolic Diseases
• Phosphorus Metabolism Disorders

Intervention

Other:
• Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/L
A change Dbic in a middle of hemodialysis
• Group 2: C) Dbic 30 -35 mmol/L B) Dbic 35- 30 mmol/L
A change Dbic in a middle of hemodialysis

Locations

Country	Name	City	State
Poland	Wieliczko Monika	Warsaw

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Warsaw	Polish Academy of Sciences, University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The blood phosphorus concentration change in hemodialysis patient	The blood phosphorus concentration change in hemodialysis patient using dialysate bicarbonate profiling	4 weeks
Secondary	The maintaining the acid-base balance in accordance with applicable recommendations.		4 weeks