Chronic Kidney DiseasePhase 1NCT01777178
Comparison of Standard Versus Low Bicarbonate Hemodialysis
A Phase 1 study testing Low bicarbonate dialysis in people with Chronic Kidney Disease and Metabolic Acidosis, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
This study will compare acid-base changes during hemodialysis treatments with a standard dialysis bath versus a lower bicarbonate dialysis bath, and aims to define the factors that limit equilibration of the bicarbonate concentration in a patient's blood with that in the dialysate. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Disease, Metabolic Acidosis
- What is being tested?
- Low bicarbonate dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2013
- Phase
- Phase 1
- 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
- Receiving chronic thrice-weekly conventional hemodialysis for at least 3 months
- Age > 18 years
Who cannot join
- Use of oral alkali within the previous month
- Hospitalization within the previous month
- Inability to provide written informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center/Jack D. Weiler Hospital
The Bronx, New York, 10461
About this study
Official title: Intradialytic Acid-base Changes and Organic Anion Production With Standard Versus Low Bicarbonate Hemodialysis
This study will compare acid-base changes during hemodialysis treatments with a standard dialysis bath versus a lower bicarbonate dialysis bath, and aims to define the factors that limit equilibration of the bicarbonate concentration in a patient's blood with that in the dialysate.
- Conditions
- Chronic Kidney Disease, Metabolic Acidosis
- Being tested
- Low bicarbonate dialysis
- Keywords
- bicarbonate, dialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low bicarbonate dialysisOther
| Study group | Role | What they receive |
|---|---|---|
| Low bicarbonate dialysis | Experimental | Not described Receives: Other: Low bicarbonate dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in beta-hydroxybutyrate clearance
Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations
Measured: 1-2 weeks
Change in lactate clearance
Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations
Measured: 1-2 weeks
Post-dialysis pH
Measured: 1-2 weeks
Post-dialysis bicarbonate
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2013
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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 K Abramowitz, MD, MS, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777178
- Sponsor's protocol ID
- 2012-684
- Status last verified
- Jun 2013
- First submitted
- 24 Jan 2013
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 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 Standard Versus Low Bicarbonate Hemodialysis
- ClinicalTrials.gov ID
- NCT01777178
- Acronym / sponsor ID
- 2012-684
- Conditions
- Chronic Kidney Disease, Metabolic Acidosis
- Keywords
- bicarbonate, dialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Jan 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.
This study will compare acid-base changes during hemodialysis treatments with a standard dialysis bath versus a lower bicarbonate dialysis bath, and aims to define the factors that limit equilibration of the bicarbonate concentration in a patient's blood with that in the dialysate.
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 dialysis | Experimental | Other: Low bicarbonate dialysis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving chronic thrice-weekly conventional hemodialysis for at least 3 months
- Age > 18 years
Key exclusion criteria (4 listed)
- Use of oral alkali within the previous month
- Hospitalization within the previous month
- Inability to provide written informed consent
- Pregnancy
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 bicarbonate dialysis | Other | Low bicarbonate dialysis |
Primary outcome
Change in beta-hydroxybutyrate clearance
Time frame: 1-2 weeks
Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations
Change in lactate clearance
Time frame: 1-2 weeks
Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations
Post-dialysis pH
Time frame: 1-2 weeks
Post-dialysis bicarbonate
Time frame: 1-2 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 30 Apr 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 K 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 Phase 1 study testing Low bicarbonate dialysis in people with Chronic Kidney Disease and Metabolic Acidosis, 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 4 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 30 Apr 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in beta-hydroxybutyrate clearance (time frame: 1-2 weeks). The study lists 4 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 30 Apr 2019.