HypertensionPhase 1NCT00259714
Dialysate Sodium Individualization in Hemodialysis
A Phase 1 study testing dialysate sodium individualization and standard dialysate sodium in people with Hypertension and Hemodialysis Patients, run by Yale University at 1 site in United States.
Trial summary
Salt and water excess is an essential mechanism of hypertension. This is particularly relevant to patients with end stage kidney disease (ESKD) on dialysis. We have demonstrated that individualization of the sodium concentration in the dialysate as to match the patient's own serum sodium concentration leads to less… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension, Hemodialysis Patients
- What is being tested?
- dialysate sodium individualization and standard dialysate sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Apr 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
- ESKD on hemodialysis
- Hypertension, defined as average pre-HD BP >150/85 mmHg or use of antihypertensive drugs
- Average pre-HD serum sodium <139 mmol/L
Who cannot join
- Intradialytic hypotension
- Atrial fibrillation or other chronic tachyarrhythmia (due to effects on measuring equipment)
- Uncontrolled hypertension (average pre-HD BP >200/105 mmHg)
- Uncontrolled diabetes mellitus (due to problems on interpretation of serum sodium values)
- Debilitating illness
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Davita New Haven Dialysis Unit
New Haven, Connecticut, 06520
About this study
Official title: Hemodynamic and Hormonal Responses to Dialysate Sodium Individualization in Hemodialysis Patients
Salt and water excess is an essential mechanism of hypertension. This is particularly relevant to patients with end stage kidney disease (ESKD) on dialysis. We have demonstrated that individualization of the sodium concentration in the dialysate as to match the patient's own serum sodium concentration leads to less thirst, interdialytic weight gain, and better BP control in hypertensive patients. In this study we will evaluate the mechanisms underlying this response by measuring systemic hemodynamics, body volume spaces, and biochemical marker of volume status.
Read the detailed description
Recent evidence from our group 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 hypertensive subjects. In this project we will evaluate the effect of dialysate sodium individualization on systemic hemodynamics, body volume compartments and biochemical markers of volume control in hypertensive hemodialysis patients. We will use a single-blind 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 3 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 3 weeks after a 1-week washout period (dialysate Na 140 mmol/L). 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 thirst scores will be measured weekly at the mid-week dialysis session. In addition, we will measure systemic hemodynamics (cardiac output and systemic vascular resistance), bioimpedance measurements of intracellular and extracellular volume, arterial stiffness (aortic augmentation index, aortic pulse wave velocity), interdialytic (44h) ambulatory BP monitoring, and plasma BNP, renin, aldosterone and norepinephrine at baseline and at the end of each block.
- Conditions
- Hypertension, Hemodialysis Patients
- Being tested
- dialysate sodium individualization, standard dialysate sodium
- Keywords
- hypertension, hemodialysis, sodium, dialysate, hemodynamics
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dialysate sodium individualizationDrug
Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized").
standard dialysate sodiumDrug
The prescribed dialysate sodium is 140 mEq/L
| Study group | Role | What they receive |
|---|---|---|
| standard dialysate sodium | Active comparator | In the control phase of the study, the prescribed dialysate sodium is 140 mEq/L Receives: Drug: standard dialysate sodium |
| dialysate sodium individualization | Experimental | .Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized"). Receives: Drug: dialysate sodium individualization |
What is being measured
The primary outcome is the main question the study is designed to answer.
BP changes on 44-h ABPM
Measured: 3 weeks
Changes in cardiac output and systemic vascular resistance
Measured: 3 weeks
Changes in intracellular and extracellular volume
Measured: 3 weeks
Secondary outcomes (3)
Changes in measured biochemical markers
Measured: 3 weeks
Changes in augmentation index
Measured: 3 weeks
Change in circadian BP profile on 44-h ABPM
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startMar 2006
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Protocol was not feasible - only 1 of 18 enrollees completed procedures.
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 HypertensionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Satellite Research
- Responsible party
- Sponsor
- Investigators
- Aldo J Peixoto, MD, Principal investigator, Yale University and VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259714
- Sponsor's protocol ID
- 0509000646
- Other IDs
- 1034978.1.R06791..721688.02
- Status last verified
- Jul 2016
- First submitted
- 28 Nov 2005
- Last updated
- 22 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 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic and Hormonal Responses to Dialysate Sodium Individualization in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00259714
- Acronym / sponsor ID
- 0509000646
- Conditions
- Hypertension, Hemodialysis Patients
- Keywords
- hypertension, hemodialysis, sodium, dialysate, hemodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol was not feasible - only 1 of 18 enrollees completed procedures.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Satellite Research
- Study start
- Mar 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 29 Nov 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.
Salt and water excess is an essential mechanism of hypertension. This is particularly relevant to patients with end stage kidney disease (ESKD) on dialysis. We have demonstrated that individualization of the sodium concentration in the dialysate as to match the patient's own serum sodium concentration leads to less thirst, interdialytic weight gain, and better BP control in hypertensive patients. In this study we will evaluate the mechanisms underlying this response by measuring systemic hemodynamics, body volume spaces, and biochemical marker of volume status.
Detailed description
Recent evidence from our group 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 hypertensive subjects. In this project we will evaluate the effect of dialysate sodium individualization on systemic hemodynamics, body volume compartments and biochemical markers of volume control in hypertensive hemodialysis patients. We will use a single-blind 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 3 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 3 weeks after a 1-week washout period (dialysate Na 140 mmol/L). 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 thirst scores will be measured weekly at the mid-week dialysis session. In addition, we will measure systemic hemodynamics (cardiac output and systemic vascular resistance), bioimpedance measurements of intracellular and extracellular volume, arterial stiffness (aortic augmentation index, aortic pulse wave velocity), interdialytic (44h) ambulatory BP monitoring, and plasma BNP, renin, aldosterone and norepinephrine at baseline and at the end of each block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard dialysate sodium | Active comparator | Drug: standard dialysate sodiumIn the control phase of the study, the prescribed dialysate sodium is 140 mEq/L |
| dialysate sodium individualization | Experimental | Drug: dialysate sodium individualization.Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized"). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ESKD on hemodialysis
- Hypertension, defined as average pre-HD BP >150/85 mmHg or use of antihypertensive drugs
- Average pre-HD serum sodium <139 mmol/L
Key exclusion criteria (6 listed)
- Intradialytic hypotension
- Atrial fibrillation or other chronic tachyarrhythmia (due to effects on measuring equipment)
- Uncontrolled hypertension (average pre-HD BP >200/105 mmHg)
- Uncontrolled diabetes mellitus (due to problems on interpretation of serum sodium values)
- Debilitating illness
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 individualizationDialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized"). | Drug | dialysate sodium individualization |
| standard dialysate sodiumThe prescribed dialysate sodium is 140 mEq/L | Drug | standard dialysate sodium |
Primary outcome
BP changes on 44-h ABPM
Time frame: 3 weeks
Changes in cardiac output and systemic vascular resistance
Time frame: 3 weeks
Changes in intracellular and extracellular volume
Time frame: 3 weeks
3 secondary outcomes
Changes in measured biochemical markers
Time frame: 3 weeks
Changes in augmentation index
Time frame: 3 weeks
Change in circadian BP profile on 44-h ABPM
Time frame: 3 weeks
Results and safety
The study was stopped early (reason given: Protocol was not feasible - only 1 of 18 enrollees completed procedures.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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.
Related trials for Hypertension
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Recruiting
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Heart Failure, Heart Diseases
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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 Connecticut 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 individualization and standard dialysate sodium in people with Hypertension and Hemodialysis Patients, 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 3 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: stopped early, as of the sponsor's last update on 22 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: Protocol was not feasible - only 1 of 18 enrollees completed procedures.). 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?
BP changes on 44-h ABPM (time frame: 3 weeks). The study lists 3 primary outcomes in all. 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 NCT00259714, 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 22 Jul 2016.