Phosphorus Metabolism DisordersNCT05861700
The Effect of Bicarbonate Profiling in Dialysis Fluid on Phosphate Removal During Hemodialysis and Blood pH
A study testing Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/L and Group 2: C) Dbic 30 -35 mmol/L B) Dbic 35- 30 mmol/L in people with Phosphorus Metabolism Disorders and Acid-Base Balance Disorder, run by Medical University of Warsaw at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phosphorus Metabolism Disorders, Acid-Base Balance Disorder
- What is being tested?
- Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/L and Group 2: C) Dbic 30 -35 mmol/L B) Dbic 35- 30 mmol/L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 21 May 2018to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- diabetes mellitus
- cachexia
- inflamation processes
- usage of sevelamer last month
- utrafiltration during dialysis more than 2500 ml
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- 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
- Keywords
- phosphorus, hemodialysis, bicarbonate, acidosis, alkalosis
- Medical subject headings
- Phosphorus Metabolism Disorders, Acidosis, Alkalosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/LOther
A change Dbic in a middle of hemodialysis
Group 2: C) Dbic 30 -35 mmol/L B) Dbic 35- 30 mmol/LOther
A change Dbic in a middle of hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Group 2: C) Dbic 30 -35 mmol/L B) Dbic 35- 30 mmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
The blood phosphorus concentration change in hemodialysis patient
The blood phosphorus concentration change in hemodialysis patient using dialysate bicarbonate profiling
Measured: 4 weeks
Secondary outcomes (1)
The maintaining the acid-base balance in accordance with applicable recommendations.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start21 May 2018
- Primary completion31 Dec 2020
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phosphorus Metabolism DisordersStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warsaw, Polish Academy of Sciences
- Responsible party
- Principal investigator, Monika Wieliczko, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861700
- Sponsor's protocol ID
- KB/91/2018
- Status last verified
- May 2023
- First submitted
- 6 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bicarbonate Profiling in Dialysis Fluid on Phosphate Removal During Hemodialysis and Blood pH
- ClinicalTrials.gov ID
- NCT05861700
- Acronym / sponsor ID
- KB/91/2018
- Keywords
- phosphorus, hemodialysis, bicarbonate, acidosis, alkalosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- University of Warsaw, Polish Academy of Sciences
- Study start
- 21 May 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/L | Active comparator | Other: Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/LWeek 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. |
| Group 2: C) Dbic 30- 35 mmol/L B) Dbic 35 -30 mmol/L | Active comparator | Other: Group 2: C) Dbic 30 -35 mmol/L B) Dbic 35- 30 mmol/LWeek 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- diabetes mellitus
- cachexia
- inflamation processes
- usage of sevelamer last month
- utrafiltration during dialysis more than 2500 ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/LA change Dbic in a middle of hemodialysis | 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/LA change Dbic in a middle of hemodialysis | Other | Group 2: C) Dbic 30- 35 mmol/L B) Dbic 35 -30 mmol/L |
Primary outcome
The blood phosphorus concentration change in hemodialysis patient
Time frame: 4 weeks
The blood phosphorus concentration change in hemodialysis patient using dialysate bicarbonate profiling
1 secondary outcome
The maintaining the acid-base balance in accordance with applicable recommendations.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: B) Dbic 35 -30 mmol/L C) Dbic 30- 35 mmol/L and Group 2: C) Dbic 30 -35 mmol/L B) Dbic 35- 30 mmol/L in people with Phosphorus Metabolism Disorders and Acid-Base Balance Disorder, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The blood phosphorus concentration change in hemodialysis patient (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.