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

NCT05861700 | Completed

• 1 other identifier: KB/91/2018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Phosphorus Metabolism Disorders; Acid-Base Balance Disorder

Keywords

phosphorus; hemodialysis; bicarbonate; acidosis; alkalosis

Outcome Measures

Primary Outcomes (1)

• The blood phosphorus concentration change in hemodialysis patient

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

  4 weeks

Secondary Outcomes (1)

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

  4 weeks

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

Interventions

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

A change Dbic in a middle of hemodialysis

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 OTHER

A change Dbic in a middle of hemodialysis

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• diabetes mellitus
• cachexia
• inflamation processes
• usage of sevelamer last month
• utrafiltration during dialysis more than 2500 ml

Sponsors & Collaborators

• Medical University of Warsaw: lead
• University of Warsaw: collaborator
• Polish Academy of Sciences: collaborator

Study Sites (1)

Wieliczko Monika

Warsaw, 01-949, Poland

Location

MeSH Terms

Conditions

Phosphorus Metabolism Disorders; Acidosis; Alkalosis

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Acid-Base Imbalance

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 17, 2023
• Study Start: May 21, 2018
• Primary Completion: December 31, 2020
• Study Completion: August 31, 2022
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

PL (1)