HemodialysisPhase 1NCT00237783
Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension
A Phase 1 study testing dialysate sodium (140 mmol/L) and individualized dialysate sodium in people with Hemodialysis and Hypotension, run by Yale University at 1 site in United States.
Trial summary
Low blood pressure (hypotension) during dialysis afflicts approximately 25% of hemodialysis patients. In this pilot study, we will evaluate the safety and effects of individualizing the sodium concentration in the dialysate according to the patient's own plasma sodium levels. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemodialysis, Hypotension
- What is being tested?
- dialysate sodium (140 mmol/L) and individualized dialysate sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Oct 2008
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodialysis patients with intradialytic hypotension
Who cannot join
- Atrial fibrillation
- Bilateral upper extremity arteriovenous access
- Average plasma sodium >139
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Hemodynamic Changes During Dialysate Sodium Individualization in Hemodialysis Patients
Low blood pressure (hypotension) during dialysis afflicts approximately 25% of hemodialysis patients. In this pilot study, we will evaluate the safety and effects of individualizing the sodium concentration in the dialysate according to the patient's own plasma sodium levels. We hypothesize that patients will have less thirst and less weight gain during the intervention leading to easier fluid removal and less episodes of hypotension.
Read the detailed description
Hypertension and intradialytic hypotension are common complications in patients on chronic maintenance hemodialysis (HD). Sodium balance is important in mediating both processes. Recent evidence shows that individualization of the sodium concentration in the dialysate to match the patient's own serum sodium results in less thirst, less interdialytic weight gain, less HD-related symptoms, and better blood pressure control. In this project we plan to evaluate the safety and tolerability of sodium individualization in hypotension-prone patients in order to generate pilot data for a larger study in patients with intradialytic hypotension. In this protocol, we will recruit 7 hypotension-prone subjects. We will use an open-label cross-over design with randomized blocks. After a 3-week baseline period where pre-HD serum sodium will be measured weekly to establish each patient's average serum sodium, subjects will be randomized to 2 weeks on standard dialysate sodium (140 mmol/L) or individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period), then crossed over to the other for another 2 weeks (total study period 7 weeks, 2 weeks baseline, 4 weeks intervention). The remainder of the dialysis prescription, prescribed dry weight and vasoactive drugs will remain unchanged throughout the study. Clinical information, pre/intra/post-HD blood pressure and hemodynamics (cardiac output and systemic vascular resistance), and the frequency and severity of intradialytic symptoms related to hypotension will be collected on HD sessions during the 4 weeks of intervention.
- Conditions
- Hemodialysis, Hypotension
- Being tested
- dialysate sodium (140 mmol/L), individualized dialysate sodium
- Keywords
- Renal dialysis, Hypotension, Dialysis solutions
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dialysate sodium (140 mmol/L)Drug
individualized dialysate sodiumDrug
individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)
| Study group | Role | What they receive |
|---|---|---|
| standard dialysate sodium (140 mmol/L) | Active comparator | dialysate sodium (140 mmol/L) Receives: Drug: dialysate sodium (140 mmol/L) |
| individualized dialysate sodium | Experimental | individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period) Receives: Drug: individualized dialysate sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intradialytic BP change
Measured: from study onset through intervention, week 7
Secondary outcomes (3)
Intradialytic changes in cardiac output and peripheral vascular resistance
Measured: from study onset through intervention, week 7
Interdialytic weight gain change
Measured: from study onset through intervention, week 7
Thirst scores
Measured: from study onset through intervention, week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Unable to recruit enough subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aldo J Peixoto, MD, Principal investigator, Yale University and VA Connecitcut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237783
- Sponsor's protocol ID
- AP0008
- Status last verified
- Jul 2016
- First submitted
- 7 Oct 2005
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
de Paula FM, Peixoto AJ, Pinto LV, Dorigo D, Patricio PJ, Santos SF. Clinical consequences of an individualized dialysate sodium prescription in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1232-8. doi: 10.1111/j.1523-1755.2004.00876.x.
PubMed 15327422
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Changes During Dialysate Sodium Individualization in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00237783
- Acronym / sponsor ID
- AP0008
- Conditions
- Hemodialysis, Hypotension
- Keywords
- Renal dialysis, Hypotension, Dialysis solutions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit enough subjects
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 12 Oct 2005 (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.
Low blood pressure (hypotension) during dialysis afflicts approximately 25% of hemodialysis patients. In this pilot study, we will evaluate the safety and effects of individualizing the sodium concentration in the dialysate according to the patient's own plasma sodium levels. We hypothesize that patients will have less thirst and less weight gain during the intervention leading to easier fluid removal and less episodes of hypotension.
Detailed description
Hypertension and intradialytic hypotension are common complications in patients on chronic maintenance hemodialysis (HD). Sodium balance is important in mediating both processes. Recent evidence shows that individualization of the sodium concentration in the dialysate to match the patient's own serum sodium results in less thirst, less interdialytic weight gain, less HD-related symptoms, and better blood pressure control. In this project we plan to evaluate the safety and tolerability of sodium individualization in hypotension-prone patients in order to generate pilot data for a larger study in patients with intradialytic hypotension. In this protocol, we will recruit 7 hypotension-prone subjects. We will use an open-label cross-over design with randomized blocks. After a 3-week baseline period where pre-HD serum sodium will be measured weekly to establish each patient's average serum sodium, subjects will be randomized to 2 weeks on standard dialysate sodium (140 mmol/L) or individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period), then crossed over to the other for another 2 weeks (total study period 7 weeks, 2 weeks baseline, 4 weeks intervention). The remainder of the dialysis prescription, prescribed dry weight and vasoactive drugs will remain unchanged throughout the study. Clinical information, pre/intra/post-HD blood pressure and hemodynamics (cardiac output and systemic vascular resistance), and the frequency and severity of intradialytic symptoms related to hypotension will be collected on HD sessions during the 4 weeks of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard dialysate sodium (140 mmol/L) | Active comparator | Drug: dialysate sodium (140 mmol/L)dialysate sodium (140 mmol/L) |
| individualized dialysate sodium | Experimental | Drug: individualized dialysate sodiumindividualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hemodialysis patients with intradialytic hypotension
Key exclusion criteria (3 listed)
- Atrial fibrillation
- Bilateral upper extremity arteriovenous access
- Average plasma sodium >139
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 |
|---|---|---|
| dialysate sodium (140 mmol/L) | Drug | standard dialysate sodium (140 mmol/L) |
| individualized dialysate sodiumindividualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period) | Drug | individualized dialysate sodium |
Primary outcome
Intradialytic BP change
Time frame: from study onset through intervention, week 7
3 secondary outcomes
Intradialytic changes in cardiac output and peripheral vascular resistance
Time frame: from study onset through intervention, week 7
Interdialytic weight gain change
Time frame: from study onset through intervention, week 7
Thirst scores
Time frame: from study onset through intervention, week 7
Results and safety
The study was stopped early (reason given: Unable to recruit enough subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Background: PubMed 15327422de Paula FM, Peixoto AJ, Pinto LV, Dorigo D, Patricio PJ, Santos SF. Clinical consequences of an individualized dialysate sodium prescription in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1232-8. doi: 10.1111/j.1523-1755.2004.00876.x.
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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.
Aldo J Peixoto, MD principal investigator
Yale University and VA Connecitcut Healthcare System
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 dialysate sodium (140 mmol/L) and individualized dialysate sodium in people with Hemodialysis and Hypotension, run by Yale University 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 26 Jul 2016. 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 was stopped early (reason given: Unable to recruit enough subjects). Results are not available in the source record.
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?
Intradialytic BP change (time frame: from study onset through intervention, week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00237783, which also lists 1 linked publication.
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 26 Jul 2016.