Chronic Kidney DiseaseNCT02098356
Comparison of High Versus Low Bicarbonate Hemodialysis
A study testing Low Bicarbonate in people with Chronic Kidney Disease and End-stage Renal Disease, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Disease, End-stage Renal Disease, Metabolic Acidosis
- What is being tested?
- Low Bicarbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Receiving chronic thrice-weekly conventional hemodialysis for at least 6 months
Who cannot join
- Use of oral alkali within the previous month
- Hospitalization within the previous month
- Inability to provide written informed consent
- Plans for kidney transplant in the next 2 months
- Planned change in phosphate binder therapy within the next month
- Pregnancy, or planned pregnancy in the next 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Intradialytic Acid-base Changes and Organic Anion Production With High Versus Low Bicarbonate Hemodialysis
This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens.
Read the detailed description
This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens. These parameters will be assessed in patients currently receiving high-bicarbonate hemodialysis as part of usual care. They will then be switched to a lower bicarbonate prescription, after which these parameters will be reassessed. The study will also examine changes in inflammatory markers, glycemic control, ketogenesis, and lipolysis.
- Being tested
- Low Bicarbonate
- Keywords
- hemodialysis, dialysis, acidosis, bicarbonate
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low BicarbonateOther
Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate
| Study group | Role | What they receive |
|---|---|---|
| Low bicarbonate | Experimental | Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate Receives: Other: Low Bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-dialysis serum bicarbonate
Change in predialysis bicarbonate
Measured: 5 weeks
Secondary outcomes (6)
serum beta-hydroxybutyrate
Change in beta-hydroxybutyrate during dialysis
Measured: 5 weeks
beta-hydroxybutyrate clearance
Change in clearance between different dialysates
Measured: 5 weeks
interleukin-6
Change during dialysis
Measured: 5 weeks
serum free fatty acids
Change during dialysis
Measured: 5 weeks
Time to recover from dialysis
Change between dialysates
Measured: 5 weeks
Dialysis symptom questionnaire
Change between dialysates
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Abramowitz, Albert Einstein College of Medicine
- Investigators
- Matthew Abramowitz, MD, MS, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098356
- Sponsor's protocol ID
- 2012-480
- Status last verified
- Apr 2018
- First submitted
- 24 Mar 2014
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradialytic Acid-base Changes and Organic Anion Production With High Versus Low Bicarbonate Hemodialysis
- ClinicalTrials.gov ID
- NCT02098356
- Acronym / sponsor ID
- 2012-480
- Keywords
- hemodialysis, dialysis, acidosis, bicarbonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Mar 2014 (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.
This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens.
Detailed description
This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens. These parameters will be assessed in patients currently receiving high-bicarbonate hemodialysis as part of usual care. They will then be switched to a lower bicarbonate prescription, after which these parameters will be reassessed. The study will also examine changes in inflammatory markers, glycemic control, ketogenesis, and lipolysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low bicarbonate | Experimental | Other: Low BicarbonateLow bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18
- Receiving chronic thrice-weekly conventional hemodialysis for at least 6 months
Key exclusion criteria (6 listed)
- Use of oral alkali within the previous month
- Hospitalization within the previous month
- Inability to provide written informed consent
- Plans for kidney transplant in the next 2 months
- Planned change in phosphate binder therapy within the next month
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 |
|---|---|---|
| Low BicarbonateLow bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate | Other | Low bicarbonate |
Primary outcome
Pre-dialysis serum bicarbonate
Time frame: 5 weeks
Change in predialysis bicarbonate
6 secondary outcomes
serum beta-hydroxybutyrate
Time frame: 5 weeks
beta-hydroxybutyrate clearance
Time frame: 5 weeks
interleukin-6
Time frame: 5 weeks
serum free fatty acids
Time frame: 5 weeks
Time to recover from dialysis
Time frame: 5 weeks
Dialysis symptom questionnaire
Time frame: 5 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 5 Jul 2019.
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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.
Matthew Abramowitz, MD, MS principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Bicarbonate in people with Chronic Kidney Disease and End-stage Renal Disease, run by Albert Einstein College of Medicine at 1 site in United States.
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 2 inclusion and 6 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 5 Jul 2019. 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 United States. 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?
Pre-dialysis serum bicarbonate (time frame: 5 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 5 Jul 2019.