Peritoneal Dialysis, Heart FailureNOSNCT06872645
Exploring Water-free Sodium Storage
A study testing 5% Dextrose/Water and 1.5% standard PD fluid in people with Peritoneal Dialysis, Heart Failure, run by Yale University at 1 site in United States.
Trial summary
The overarching goal of this proposal is to definitively establish if acute water free Na storage and release occurs, if the amount stored/released is of a quantity that is physiologically relevant, and if the location is intracellular vs. extracellular. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis, Heart Failure
- What is being tested?
- 5% Dextrose/Water and 1.5% standard PD fluid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ESRD Patients actively undergoing PD with a reliably functioning PD catheter
- Systolic blood pressure > 130 mmHg
- Serum sodium >135 mmol/L
- daily urine output < 400ml
- stable PD prescription for at least 2 months without requirement of 4.25% glucose PD solution
- PD vintage of at least 6 months
- Euvolemic as defined by the patient at their dry weight and free of any signs or symptoms of volume overload, per referring nephrologist
Who cannot join
- Poorly controlled diabetes with hemoglobin A1C>9%
- 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
- Anemia with hemoglobin <8g/dL
- Inability to give written informed consent or follow study protocol.
- Urinary incontinence
- Body weight < 60kg
- gastrointestinal disease that causes diarrhea or expectation of sodium losses in stool.
- use of amiodarone in the last 6 months (which will interfere with tissue iodine ascertainment).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06510
Veena Rao, PhD, 203-785-7917, veena.s.rao@yale.edu
Jeffrey Testani, MD
About this study
The overarching goal of this proposal is to definitively establish if acute water free Na storage and release occurs, if the amount stored/released is of a quantity that is physiologically relevant, and if the location is intracellular vs. extracellular.
Read the detailed description
This study is designed as a an ultra-rigorous inpatient balance study. The main purpose of the study is to determine if significant mobilizable non- extracellular volume (ECV) Na storage occurs in humans. This is a randomized, blinded crossover study. Patients will be randomized to Na free 5% dextrose solution or 1.5% standard peritoneal dialysis (PD) fluid (Dianeal 1.5% low calcium PD solution with standard 132 mmol/L Na and osmolarity of 344 mOsmol/L) and will receive treatment for 5 days, following a 6 week wash out patient will return to undergo 5 days of alternate therapy.
- Conditions
- Peritoneal Dialysis, Heart Failure
- Being tested
- 5% Dextrose/Water, 1.5% standard PD fluid
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Dextrose/WaterDrug
Patients will be randomized to undergo up to two-hour dwell with 5% dextrose in sterile water for 5 days
1.5% standard PD fluidDrug
Patients will be randomized to undergo up to two-hour dwell with 1.5% standard PD fluid for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 5% dextrose peritoneal dialysis, 2-hour dwell | Experimental | Individuals will receive up to 2 liters of 5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days Receives: Drug: 5% Dextrose/Water |
| 1.5% dextrose peritoneal dialysis, 2-hour dwell | Active comparator | Individuals will receive up to 2 liters of 1.5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days Receives: Drug: 1.5% standard PD fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Water free Na removal over the 5-day intervention
Water free Na removal will be calculated as [Water Free Na= ((ΔTBW (L) * serum Na (mmol/L)) - Na balance (mmol)]. This will be compared between 5% dextrose Na removal period and 1.5% dextrose standard PD neutral Na balance period
Measured: Daily for 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start3 Oct 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis, Heart FailureStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, blinded crossover study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Testani, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872645
- Sponsor's protocol ID
- 2000039499
- Other IDs
- 1R01DK138155
- Acronym
- NOS
- Status last verified
- May 2026
- First submitted
- 6 Mar 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Water-free Sodium Storage
- ClinicalTrials.gov ID
- NCT06872645
- Acronym / sponsor ID
- NOS / 2000039499
- Conditions
- Peritoneal Dialysis, Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 12 Mar 2025 (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.
The overarching goal of this proposal is to definitively establish if acute water free Na storage and release occurs, if the amount stored/released is of a quantity that is physiologically relevant, and if the location is intracellular vs. extracellular.
Detailed description
This study is designed as a an ultra-rigorous inpatient balance study. The main purpose of the study is to determine if significant mobilizable non- extracellular volume (ECV) Na storage occurs in humans. This is a randomized, blinded crossover study. Patients will be randomized to Na free 5% dextrose solution or 1.5% standard peritoneal dialysis (PD) fluid (Dianeal 1.5% low calcium PD solution with standard 132 mmol/L Na and osmolarity of 344 mOsmol/L) and will receive treatment for 5 days, following a 6 week wash out patient will return to undergo 5 days of alternate therapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, blinded crossover study
| Arm | Type | Receives |
|---|---|---|
| 5% dextrose peritoneal dialysis, 2-hour dwell | Experimental | Drug: 5% Dextrose/WaterIndividuals will receive up to 2 liters of 5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days |
| 1.5% dextrose peritoneal dialysis, 2-hour dwell | Active comparator | Drug: 1.5% standard PD fluidIndividuals will receive up to 2 liters of 1.5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ESRD Patients actively undergoing PD with a reliably functioning PD catheter
- Systolic blood pressure > 130 mmHg
- Serum sodium >135 mmol/L
- daily urine output < 400ml
- stable PD prescription for at least 2 months without requirement of 4.25% glucose PD solution
Key exclusion criteria (8 listed)
- Poorly controlled diabetes with hemoglobin A1C>9%
- 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
- Anemia with hemoglobin <8g/dL
- Inability to give written informed consent or follow study protocol.
- Urinary incontinence
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 |
|---|---|---|
| 5% Dextrose/WaterPatients will be randomized to undergo up to two-hour dwell with 5% dextrose in sterile water for 5 days | Drug | 5% dextrose peritoneal dialysis, 2-hour dwell |
| 1.5% standard PD fluidPatients will be randomized to undergo up to two-hour dwell with 1.5% standard PD fluid for 5 days | Drug | 1.5% dextrose peritoneal dialysis, 2-hour dwell |
Primary outcome
Water free Na removal over the 5-day intervention
Time frame: Daily for 5 days
Water free Na removal will be calculated as [Water Free Na= ((ΔTBW (L) * serum Na (mmol/L)) - Na balance (mmol)]. This will be compared between 5% dextrose Na removal period and 1.5% dextrose standard PD neutral Na balance period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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The Effect of Physical Activity Level Evaluated by Wrist-wearable Devices on Cardiovascular Disease Risk and Other Outcomes in Peritoneal Dialysis Patients
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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.
Jeffrey Testani, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5% Dextrose/Water and 1.5% standard PD fluid in people with Peritoneal Dialysis, Heart Failure, 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veena Rao, PhD (2037857917, veena.s.rao@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Water free Na removal over the 5-day intervention (time frame: Daily for 5 days). 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 13 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.