Hemodialysis ComplicationPhase 2DeSaLTNCT03144817
Dialysate Sodium Lowering Trial
A Phase 2 study testing Dialysate Sodium Lowering in people with Hemodialysis Complication and Fluid Overload, run by Tufts Medical Center at 1 site in United States.
Trial summary
This is a pilot randomized clinical trial in which patients treated with 3X per weekly conventional hemodialysis will be treated to a dialysate sodium 135 mEq/L vs. 138 mEq/L and followed for safety and tolerability, effects on BP and volume. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication, Fluid Overload, Dialysis Disequilibrium
- What is being tested?
- Dialysate Sodium Lowering
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2017to 2 Apr 2019
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Patients undergoing thrice weekly in-center conventional HD
- At least 90 days since start of hemodialysis
- Absence of pulmonary edema / signs of fluid overload on physical exam
- Currently dialyzing at a DNa >=137 mEq/L
- Single session Kt/V >=1.3 each month for the past 2 months
Show all 11Show fewer
- Hypertensive, defined by a pre-dialysis BP of >140/90 or treatment with 1 or more antihypertensive agents
- No more than 1 skipped treatment and no more than 1 session per month shortened by >10 min
- Life expectancy >12 months
- Able to provide Informed Consent
- Speaks and understands English
Who cannot join
- Prone to IDH, defined as IDH occurring in >10% of treatments in the past 3 months. IDH will be defined as symptoms (e.g. cramps, dizziness, loss of consciousness) and/or intra- or post-dialytic systolic BP <90 mm Hg and/or use of intervention(s) (UF goal lowered, treatment stopped early, or saline given) because of IDH
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot randomized clinical trial in which patients treated with 3X per weekly conventional hemodialysis will be treated to a dialysate sodium 135 mEq/L vs. 138 mEq/L and followed for safety and tolerability, effects on BP and volume.
Read the detailed description
This is a pilot randomized clinical trial in which hypertensive hemodialysis patients will be randomized to a low dialysate sodium (Na) of 135 mEq/L or a standard dialysate Na of 138 mEq/L. Patients will be randomized 2:1 to the low arm. Dialysate Na will be lowered 1 mEq/L every 2 weeks, as tolerated. Tolerance will be assessed by symptoms, intradialytic hypotension (IDH) episodes (systolic BP <90 or intervention for symptoms or BP drop during dialysis), achievement of dry weight. The trial will last for 6 to 12 months, for an individual, depending on when they entered the trial. The primary outcome is feasibility and safety of using the lower dialysate sodium which is assessed by symptoms during or immediately after dialysis, intradialytic hypotension episodes and the frequency of emergency room visits and hospitalizations. Several secondary outcomes will be measured including blood pressure prior to dialysis and at home, change in plasma Na over time, dry weight, post-dialysis weight, interdialytic weight change, symptoms of thirst and dry mouth, self-reported dialysis recovery time, relative blood volume change during a single treatment (via 'Critline') and, in patients without an implanted electronic device, extraceullular fluid volume (via bioimpedance).
- Conditions
- Hemodialysis Complication, Fluid Overload, Dialysis Disequilibrium, Intra-dialytic Hypotension, Hypertension
- Being tested
- Dialysate Sodium Lowering
- Keywords
- hemodialysis, fluid overload, dialysis disequilibrium, intra-dialytic hypotension, dialysate sodium lowering
- Medical subject headings
- Edema, Dysequilibrium syndrome, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysate Sodium LoweringOther
Dialysate sodium is lowered until nadir sodium level is reached. Participant dialyzes at this sodium level until end of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Intervention Group | Experimental | Intervention group will dialyze with dialysate Na 135 mEq/L. Receives: Other: Dialysate Sodium Lowering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Intradialytic Hypotension
IDH is determined by review of blood pressures (measured every 30 minutes during dialysis), symptoms (recorded by the nurse during the dialysis treatment and reviewed at Q2 weekly face to face visits by the study team) and the need for intervention (targeted ultrafiltration goal was reduced; treatment was terminated early or saline given for intradialytic hypotension. IDH is defined by any 1 (or more of the following) 1) lowest intradialytic Systolic BP <90 mm Hg or 2) intradialytic symptoms (cramps, lightheadedness, nausea +/-vomiting, diaphoresis, loss of consciousness or seizure) OR 3) intervention performed for symptoms of IDH or lowest intradialytic BP <90 mm Hg.
The # IDH events (meeting 1 or more of the 3 criteria above) per 100 treatments will be compared across treatment arms.
Measured: Baseline period through study completion, an average of 6 months
Dialysis Dysequilibrium (Safety)
Ascertained via self-report on a questionnaire that asks about the frequency of symptoms suggestive of DD occurring during or immediately after dialysis. The symptoms are: headache, nausea +/- vomiting, confusion, drowsiness, muscle twitching, blurred vision. There are 5 response options ranging from never through to very often for each question. The questionnaire is administered at baseline, at 6 weeks, and Q3 months thereafter. The change in frequency of each symptom will be compared across arms.
Measured: Baseline period through study completion, an average of 6 months
Frequency of ER visits and hospitalizations (safety)
The frequency of ER visits and hospitalizations will be ascertained at Q2 weekly study visits. The # of events per time at risk will be compared across treatment arms.
Measured: Baseline through study completion
Frequency of patients treated to a dialysate Na 135 mEq/L at end of study (feasibility)
Among those assigned to Dialysate Na 135 mEq/l as the denominator, the # actually continuing to dialyze at this level during the last two weeks of study follow-up.
Measured: Last 2 weeks of Follow-up
Secondary outcomes (11)
Pre- and post-dialysis Plasma Sodium
Taken from lab draws immediately before and after start of dialysis treatment.
Measured: Baseline period through study completion, an average of 6 months
Dialysate Sodium
Sample of dialysate sodium taken 30 minutes after start of dialysis treatment.
Measured: Baseline period through study completion, an average of 6 months
Relative Blood Volume
Determined using CRIT LINE III monitors.
Measured: Baseline period through study completion, an average of 6 months
Bioimpedance Analysis
Water volume and bioimpedance results will be determined using InBodyS10 device.
Measured: Baseline period through study completion, an average of 6 months
Interdialytic Weight Gain
Determined by analysis of treatment sheets.
Measured: Baseline period through study completion, an average of 6 months
Post Dialysis Weight
Determined by analysis of treatment sheets.
Measured: Baseline period through study completion, an average of 6 months
Estimated Dry Weight
Determined by analysis of treatment sheets.
Measured: Baseline period through study completion, an average of 6 months
Pre- and Post-dialysis Sitting Blood Pressure
Determined by analysis of treatment sheets.
Measured: Baseline period through study completion, an average of 6 months
Home Blood Pressure Monitoring
Participants will use a LifeSource blood pressure monitor to measure their blood pressure weekly at home.
Measured: Baseline period through study completion, an average of 6 months
Sodium Loss during Dialysis
Calculated according to the formula: pre-dialysis total body Na - post-dialysis total body Na, where the volume of distribution in the extracellular space is estimated as 0.58*target weight.
Measured: Baseline period through study completion, an average of 6 months
Thirst and Xerostomia
Thirst and Xerostomia will be measured via validated, self-administered questionnaires, the 'Dialysis Thirst Inventory' and the 'Xerostomia Inventory' , respectively (BotsCP et al, Kidney International:66; 2004).
Change in each inventory score from baseline to the end of the study will be compared by treatment arm.
Measured: Baseline through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start26 Apr 2017
- Primary completion19 Dec 2018
- Study completion2 Apr 2019
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 Hemodialysis ComplicationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dialysis Clinic, Inc., InBody
- Responsible party
- Sponsor
- Investigators
- Dana Miskulin, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144817
- Sponsor's protocol ID
- 12393
- Acronym
- DeSaLT
- Status last verified
- May 2019
- First submitted
- 27 Apr 2017
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.
PubMed 39498822
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialysate Sodium Lowering Trial
- ClinicalTrials.gov ID
- NCT03144817
- Acronym / sponsor ID
- DeSaLT / 12393
- Conditions
- Hemodialysis Complication, Fluid Overload, Dialysis Disequilibrium, Intra-dialytic Hypotension, Hypertension
- Keywords
- hemodialysis, fluid overload, dialysis disequilibrium, intra-dialytic hypotension, dialysate sodium lowering
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Dialysis Clinic, Inc., InBody
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 9 May 2017 (actual)
- 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 is a pilot randomized clinical trial in which patients treated with 3X per weekly conventional hemodialysis will be treated to a dialysate sodium 135 mEq/L vs. 138 mEq/L and followed for safety and tolerability, effects on BP and volume.
Detailed description
This is a pilot randomized clinical trial in which hypertensive hemodialysis patients will be randomized to a low dialysate sodium (Na) of 135 mEq/L or a standard dialysate Na of 138 mEq/L. Patients will be randomized 2:1 to the low arm. Dialysate Na will be lowered 1 mEq/L every 2 weeks, as tolerated. Tolerance will be assessed by symptoms, intradialytic hypotension (IDH) episodes (systolic BP <90 or intervention for symptoms or BP drop during dialysis), achievement of dry weight. The trial will last for 6 to 12 months, for an individual, depending on when they entered the trial. The primary outcome is feasibility and safety of using the lower dialysate sodium which is assessed by symptoms during or immediately after dialysis, intradialytic hypotension episodes and the frequency of emergency room visits and hospitalizations. Several secondary outcomes will be measured including blood pressure prior to dialysis and at home, change in plasma Na over time, dry weight, post-dialysis weight, interdialytic weight change, symptoms of thirst and dry mouth, self-reported dialysis recovery time, relative blood volume change during a single treatment (via 'Critline') and, in patients without an implanted electronic device, extraceullular fluid volume (via bioimpedance).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Intervention Group | Experimental | Other: Dialysate Sodium LoweringIntervention group will dialyze with dialysate Na 135 mEq/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age >18 years
- Patients undergoing thrice weekly in-center conventional HD
- At least 90 days since start of hemodialysis
- Absence of pulmonary edema / signs of fluid overload on physical exam
- Currently dialyzing at a DNa >=137 mEq/L
Key exclusion criteria (2 listed)
- Prone to IDH, defined as IDH occurring in >10% of treatments in the past 3 months. IDH will be defined as symptoms (e.g. cramps, dizziness, loss of consciousness) and/or intra- or post-dialytic systolic BP <90 mm Hg and/or use of intervention(s) (UF goal lowered, treatment stopped early, or saline given) because of IDH
- 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 |
|---|---|---|
| Dialysate Sodium LoweringDialysate sodium is lowered until nadir sodium level is reached. Participant dialyzes at this sodium level until end of follow-up. | Other | Intervention Group |
Primary outcome
Frequency of Intradialytic Hypotension
Time frame: Baseline period through study completion, an average of 6 months
IDH is determined by review of blood pressures (measured every 30 minutes during dialysis), symptoms (recorded by the nurse during the dialysis treatment and reviewed at Q2 weekly face to face visits by the study team) and the need for intervention (targeted ultrafiltration goal was reduced; treatment was terminated early or saline given for intradialytic hypotension. IDH is defined by any 1 (or more of the following) 1) lowest intradialytic Systolic BP <90 mm Hg or 2) intradialytic symptoms (cramps, lightheadedness, nausea +/-vomiting, diaphoresis, loss of consciousness or seizure) OR 3) intervention performed for symptoms of IDH or lowest intradialytic BP <90 mm Hg. The # IDH events (meeting 1 or more of the 3 criteria above) per 100 treatments will be compared across treatment arms.
Dialysis Dysequilibrium (Safety)
Time frame: Baseline period through study completion, an average of 6 months
Ascertained via self-report on a questionnaire that asks about the frequency of symptoms suggestive of DD occurring during or immediately after dialysis. The symptoms are: headache, nausea +/- vomiting, confusion, drowsiness, muscle twitching, blurred vision. There are 5 response options ranging from never through to very often for each question. The questionnaire is administered at baseline, at 6 weeks, and Q3 months thereafter. The change in frequency of each symptom will be compared across arms.
Frequency of ER visits and hospitalizations (safety)
Time frame: Baseline through study completion
The frequency of ER visits and hospitalizations will be ascertained at Q2 weekly study visits. The # of events per time at risk will be compared across treatment arms.
Frequency of patients treated to a dialysate Na 135 mEq/L at end of study (feasibility)
Time frame: Last 2 weeks of Follow-up
Among those assigned to Dialysate Na 135 mEq/l as the denominator, the # actually continuing to dialyze at this level during the last two weeks of study follow-up.
11 secondary outcomes
Pre- and post-dialysis Plasma Sodium
Time frame: Baseline period through study completion, an average of 6 months
Dialysate Sodium
Time frame: Baseline period through study completion, an average of 6 months
Relative Blood Volume
Time frame: Baseline period through study completion, an average of 6 months
Bioimpedance Analysis
Time frame: Baseline period through study completion, an average of 6 months
Interdialytic Weight Gain
Time frame: Baseline period through study completion, an average of 6 months
Post Dialysis Weight
Time frame: Baseline period through study completion, an average of 6 months
Estimated Dry Weight
Time frame: Baseline period through study completion, an average of 6 months
Pre- and Post-dialysis Sitting Blood Pressure
Time frame: Baseline period through study completion, an average of 6 months
Home Blood Pressure Monitoring
Time frame: Baseline period through study completion, an average of 6 months
Sodium Loss during Dialysis
Time frame: Baseline period through study completion, an average of 6 months
Thirst and Xerostomia
Time frame: Baseline through study completion, an average of 6 months
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 3 Jun 2019.
- Derived from this study: PubMed 39498822Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.
- Individual participant dataSharing planned: Undecided
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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.
Dana Miskulin, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dialysate Sodium Lowering in people with Hemodialysis Complication and Fluid Overload, run by Tufts Medical Center 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 11 inclusion and 2 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 3 Jun 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Frequency of Intradialytic Hypotension (time frame: Baseline period through study completion, an average of 6 months). 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?
On the ClinicalTrials.gov record for NCT03144817, 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 3 Jun 2019.