Chronic Dialysis PatientsPhase 4NCT01930370
Effect of Varied Dialysate Bicarbonate Levels on Phosphate and Potassium Removal
A Phase 4 study testing Bicarbonate hemodialysis solution (low concentration) and Bicarbonate hemodialysis solution (high concentration) in people with Chronic Dialysis Patients, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Modeling of bicarbonate within the dialysate fluid, specifically a lower than standard concentration has been suggested in facilitating the removal of phosphate and potassium. To test this hypothesis, the study will use a cross-over study design to evaluate phosphate and potassium removal during dialysis by altering… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Chronic Dialysis Patients
- What is being tested?
- Bicarbonate hemodialysis solution (low concentration) and Bicarbonate hemodialysis solution (high concentration)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Dec 2014
- Phase
- Phase 4
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients 0-18 years old
- Patients receiving maintenance hemodialysis* for a total of 9-15 hours per week
- Pre-dialysis serum potassium value between 4.0 and 6.5 mmol/L on the first day of the treatment protocol
- Pre-dialysis serum phosphate value greater than low normal for age on the first day of the treatment protocol
- Pre-dialysis serum bicarbonate (total CO2) value between 18 and 30 mmol/L on the first day of the treatment protocol
- Pre-dialysis corrected calcium value between 1.80-2.85 mmol/L on the first day of the treatment protocol
Who cannot join
- Hemodynamically unstable patients (requiring inotropes or midodrine for support).
- Pre-dialysis potassium value < 4.0 or > 6.5 mmol/L on the first day of the treatment protocol
- Pre-dialysis serum phosphate value less than low normal for age on the first day of the treatment protocol (i.e. hypophosphatemia)
- Pre-dialysis serum bicarbonate (total CO2) value <18 or > 30 mmol/L on the first day of the treatment protocol
- Pre-dialysis corrected calcium <1.8 and >2.85 mmol/L on the first day of the treatment protocol
- Patients mechanically ventilated
- Drugs that could modify internal phosphate and potassium balance such as insulin, bicarbonate injection, hypertonic dextrose solution or mannitol infusion during HD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Varied Dialysate Bicarbonate Levels on Phosphate and Potassium Removal: A Pilot Study
Modeling of bicarbonate within the dialysate fluid, specifically a lower than standard concentration has been suggested in facilitating the removal of phosphate and potassium. To test this hypothesis, the study will use a cross-over study design to evaluate phosphate and potassium removal during dialysis by altering bicarbonate concentration in dialysis fluid (i.e. high bicarbonate, standard bicarbonate washout, low bicarbonate), and compare the effects of the different dialysate bicarbonate concentrations on the removal of phosphate and potassium during hemodialysis
Read the detailed description
Elevation of blood phosphate levels in chronic dialysis patients is associated with increased mortality due to cardiovascular events, and if sustained leads to hyperactivity of parathyroid glands and renal bone disease. Similarly, increased calcium-phosphate product as a result of elevated levels of phosphate in the blood is an additional risk factor for vascular calcification. Elevated blood potassium levels is another major electrolyte disorder in patients with advanced renal disease which is potentially life threatening. Therefore control of blood phosphate and potassium levels is a fundamental component of treatment for end stage renal disease. Management of hyperelectrolyte levels in renal failure patients requires restriction of phosphate and potassium intake through dietary measures, promotion of excretion via GI tract through medication delivery (i.e. supplementary binders), and removal through dialysis. All these strategies come with limitations however, specifically adherence to dietary restrictions and medication compliance is poor due to lack of immediate repercussions, as well as the complex kinetics involved with removal via dialysis given the dependence on duration and frequency of dialysis whose manipulation is limited by time considerations for the patient and scheduling issues in the dialysis unit.
- Conditions
- Chronic Dialysis Patients
- Being tested
- Bicarbonate hemodialysis solution (low concentration), Bicarbonate hemodialysis solution (high concentration)
- Keywords
- pediatrics, phosphate and postassium revmoval, dialysate bicarbonate modeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicarbonate hemodialysis solution (low concentration)Drug
One-week experimental session (3 dialysis treatments) with low dialysate bicarbonate (28 mmol/L)
Bicarbonate hemodialysis solution (high concentration)Drug
One-week experimental session with high dialysate bicarbonate (38 mmol/L)
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients | Experimental | Each patient will be evaluated during a total of 3.5 weeks correlating to routine dialysis treatment appointments. Each participant will start with low bicarbonate, followed by the washout phase (standard bicarbonate), then high bicarbonate, finishing with the follow up period. Dialysis prescription is standardized for each patient throughout the entire 3.5 week study period. Receives: Drug: Bicarbonate hemodialysis solution (low concentration); Drug: Bicarbonate hemodialysis solution (high concentration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phosphate/Potassium Removal
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):
Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Measured: Dialysis Treatment 1 (Day 1) - Pre and Post dialysis (0hrs and 4hours)
Phosphate/Potassium Removal
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):
Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Measured: Dialysis Treatment 2 (Day 2) - Pre and Post dialysis (0hrs and 4hours)
Phosphate/Potassium Removal
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):
Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Measured: Dialysis Treatment 3 (Day 3) - Pre and Post dialysis (0hrs, 4hours, 5hours)
Phosphate/Potassium Removal
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):
Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Measured: Dialysis Treatment 7 (Day 15) - Pre and Post dialysis (0hrs, 4hours)
Phosphate/Potassium Removal
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):
Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Measured: Dialysis Treatment 8 (Day 16) - Pre and Post dialysis (0hrs, 4hours)
Phosphate/Potassium Removal
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment):
Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Measured: Dialysis Treatment 9 (Day 17) - Pre and Post dialysis (0hrs, 4hours, 5hours)
Secondary outcomes (6)
Plasma Phosphate Levels
Measurement of the biochemical (serum) parameters of Phosphate for each dialysis treatment
Measured: Baseline and Post Dialysis (4hours)
Plasma Potassium Levels
Measurement of the biochemical (serum) parameters of Potassium for each dialysis treatment
Measured: Pre and Post Dialysis
Total Plasma CO2 (bicarbonate)
Measurement of the biochemical (serum) parameters of CO2 (bicarbonate) for each dialysis treatment
Measured: Pre and Post Dialysis (0 and 4hours)
Corrected Calcium Measurement
Biochemical measurement of the blood for corrected caclium (calcium and albumin) for each dialysis treatment
Measured: Pre and Post Dialysis (0 and 4hours)
Dialysis Adequacy (Kt/ V)
Measurement of Blood urea will be performed for each dialysis treatment.
Measured: Pre and Post Dialysis (0 and 4hours)
Dialysis Adequacy (Urea Reduction Ratio -URR)
Measurement of Blood urea will be performed for each dialysis treatment.
Measured: Pre and Post Dialysis (0 and 4hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startMar 2010
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Dialysis PatientsStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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 4
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Harvey, The Hospital for Sick Children
- Investigators
- Denis Geary, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930370
- Sponsor's protocol ID
- 1000014657
- Status last verified
- May 2015
- First submitted
- 23 Aug 2013
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Varied Dialysate Bicarbonate Levels on Phosphate and Potassium Removal: A Pilot Study
- ClinicalTrials.gov ID
- NCT01930370
- Acronym / sponsor ID
- 1000014657
- Conditions
- Chronic Dialysis Patients
- Keywords
- pediatrics, phosphate and postassium revmoval, dialysate bicarbonate modeling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Aug 2013 (estimated)
- 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.
Modeling of bicarbonate within the dialysate fluid, specifically a lower than standard concentration has been suggested in facilitating the removal of phosphate and potassium. To test this hypothesis, the study will use a cross-over study design to evaluate phosphate and potassium removal during dialysis by altering bicarbonate concentration in dialysis fluid (i.e. high bicarbonate, standard bicarbonate washout, low bicarbonate), and compare the effects of the different dialysate bicarbonate concentrations on the removal of phosphate and potassium during hemodialysis
Detailed description
Elevation of blood phosphate levels in chronic dialysis patients is associated with increased mortality due to cardiovascular events, and if sustained leads to hyperactivity of parathyroid glands and renal bone disease. Similarly, increased calcium-phosphate product as a result of elevated levels of phosphate in the blood is an additional risk factor for vascular calcification. Elevated blood potassium levels is another major electrolyte disorder in patients with advanced renal disease which is potentially life threatening. Therefore control of blood phosphate and potassium levels is a fundamental component of treatment for end stage renal disease. Management of hyperelectrolyte levels in renal failure patients requires restriction of phosphate and potassium intake through dietary measures, promotion of excretion via GI tract through medication delivery (i.e. supplementary binders), and removal through dialysis. All these strategies come with limitations however, specifically adherence to dietary restrictions and medication compliance is poor due to lack of immediate repercussions, as well as the complex kinetics involved with removal via dialysis given the dependence on duration and frequency of dialysis whose manipulation is limited by time considerations for the patient and scheduling issues in the dialysis unit.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | Experimental | Drug: Bicarbonate hemodialysis solution (low concentration), Drug: Bicarbonate hemodialysis solution (high concentration)Each patient will be evaluated during a total of 3.5 weeks correlating to routine dialysis treatment appointments. Each participant will start with low bicarbonate, followed by the washout phase (standard bicarbonate), then high bicarbonate, finishing with the follow up period. Dialysis prescription is standardized for each patient throughout the entire 3.5 week study period. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients 0-18 years old
- Patients receiving maintenance hemodialysis* for a total of 9-15 hours per week
- Pre-dialysis serum potassium value between 4.0 and 6.5 mmol/L on the first day of the treatment protocol
- Pre-dialysis serum phosphate value greater than low normal for age on the first day of the treatment protocol
- Pre-dialysis serum bicarbonate (total CO2) value between 18 and 30 mmol/L on the first day of the treatment protocol
Key exclusion criteria (7 listed)
- Hemodynamically unstable patients (requiring inotropes or midodrine for support).
- Pre-dialysis potassium value < 4.0 or > 6.5 mmol/L on the first day of the treatment protocol
- Pre-dialysis serum phosphate value less than low normal for age on the first day of the treatment protocol (i.e. hypophosphatemia)
- Pre-dialysis serum bicarbonate (total CO2) value <18 or > 30 mmol/L on the first day of the treatment protocol
- Pre-dialysis corrected calcium <1.8 and >2.85 mmol/L on the first day of the treatment protocol
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 |
|---|---|---|
| Bicarbonate hemodialysis solution (low concentration)One-week experimental session (3 dialysis treatments) with low dialysate bicarbonate (28 mmol/L) | Drug | Hemodialysis patients |
| Bicarbonate hemodialysis solution (high concentration)One-week experimental session with high dialysate bicarbonate (38 mmol/L) | Drug | Hemodialysis patients |
Primary outcome
Phosphate/Potassium Removal
Time frame: Dialysis Treatment 1 (Day 1) - Pre and Post dialysis (0hrs and 4hours)
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment): Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Phosphate/Potassium Removal
Time frame: Dialysis Treatment 2 (Day 2) - Pre and Post dialysis (0hrs and 4hours)
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment): Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Phosphate/Potassium Removal
Time frame: Dialysis Treatment 3 (Day 3) - Pre and Post dialysis (0hrs, 4hours, 5hours)
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment): Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Phosphate/Potassium Removal
Time frame: Dialysis Treatment 7 (Day 15) - Pre and Post dialysis (0hrs, 4hours)
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment): Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Phosphate/Potassium Removal
Time frame: Dialysis Treatment 8 (Day 16) - Pre and Post dialysis (0hrs, 4hours)
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment): Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
Phosphate/Potassium Removal
Time frame: Dialysis Treatment 9 (Day 17) - Pre and Post dialysis (0hrs, 4hours, 5hours)
The amount of phosphate/potassium removed with each dialysis as measured from dialysate aliquots and total calculated volume of dialysate. The following formula will be used to calculate Phosphate (PO4) and Potassium (K) mass removal (mmol/treatment): Calculation based on the concentration of K/PO4 (mmol/L) in dialysate x (calculated volume of dialysate + calculated volume of ultrafiltrate)
6 secondary outcomes
Plasma Phosphate Levels
Time frame: Baseline and Post Dialysis (4hours)
Plasma Potassium Levels
Time frame: Pre and Post Dialysis
Total Plasma CO2 (bicarbonate)
Time frame: Pre and Post Dialysis (0 and 4hours)
Corrected Calcium Measurement
Time frame: Pre and Post Dialysis (0 and 4hours)
Dialysis Adequacy (Kt/ V)
Time frame: Pre and Post Dialysis (0 and 4hours)
Dialysis Adequacy (Urea Reduction Ratio -URR)
Time frame: Pre and Post Dialysis (0 and 4hours)
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 28 May 2015.
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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.
Denis Geary, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bicarbonate hemodialysis solution (low concentration) and Bicarbonate hemodialysis solution (high concentration) in people with Chronic Dialysis Patients, run by The Hospital for Sick Children at 1 site in Canada.
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 6 inclusion and 7 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 28 May 2015. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Phosphate/Potassium Removal (time frame: Dialysis Treatment 1 (Day 1) - Pre and Post dialysis (0hrs and 4hours)). The study lists 6 primary outcomes in all. 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 28 May 2015.