Potential Applications for Heart FailureEarly Phase 1NCT03801226
Zero Sodium Peritoneal Dialysate Protocol Pilot Study
A Early Phase 1 study testing Two-hour dwell with 10% dextrose in sterile water and Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose in people with Potential Applications for Heart Failure and Volume Overload, run by Yale University at 1 site in United States.
Trial summary
The following pilot study will be undertaken to determine the effects of use of a zero-sodium peritoneal dialysate solution (10% dextrose in sterile water) on sodium removal as compared to a standard peritoneal dialysis solution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Potential Applications for Heart Failure, Volume Overload
- What is being tested?
- Two-hour dwell with 10% dextrose in sterile water and Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 31 May 2019
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients actively undergoing peritoneal dialysis (PD) with a functioning PD catheter
- PD vintage < 3 years
- As judged by treating nephrologist to be at or above optimal volume status (i.e., not dehydrated)
Who cannot join
- Uncontrolled diabetes with frequent episodes of severe hyperglycemia
- Systolic blood pressure < 100 mmHg
- Serum sodium < 130 mEq/L
- 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
- Anemia with hemoglobin <8 g/dL
- Serum bicarbinate < 18 mEq/L
- Anuric renal failure
- Inability to give written informed consent or follow study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study
The following pilot study will be undertaken to determine the effects of use of a zero-sodium peritoneal dialysate solution (10% dextrose in sterile water) on sodium removal as compared to a standard peritoneal dialysis solution.
Read the detailed description
While heart failure (HF) is generally regarded as the inability of the heart to pump sufficient blood, on a population level, volume overload is the primary driver of morbidity and hospitalization. The signs and symptoms of volume overload are driven by water accumulation, which is initially driven by sodium retention. This overall goal of this study is to investigate the ability to remove sodium through use of a zero-sodium solution in peritoneal dialysis.
- Being tested
- Two-hour dwell with 10% dextrose in sterile water, Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose
- Keywords
- Peritoneal dialysis
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-hour dwell with 10% dextrose in sterile waterDrug
Patients will be randomized to undergo a two-hour dwell with 10% dextrose in sterile water at their first or second study visit and will receive the alternate intervention at the other study visit.
Two-hour dwell with Dianeal Low-Calcium with 4.25% DextroseDrug
Patients will be randomized to undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first or second study visit and will receive the alternate intervention at the other study visit.
| Study group | Role | What they receive |
|---|---|---|
| 10% dextrose in sterile water | Experimental | Patients randomized to this arm will undergo a two-hour dwell with 10% dextrose in sterile water at their first visit and Dianeal Low-Calcium with 4.25% Dextrose at their second visit. Receives: Drug: Two-hour dwell with 10% dextrose in sterile water; Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose |
| Dianeal Low-Calcium with 4.25% Dextrose | Active comparator | Patients randomized to this arm will undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first visit and 10% dextrose in sterile water at their second visit. Receives: Drug: Two-hour dwell with 10% dextrose in sterile water; Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event
Protocol discontinuation will be defined by premature draining of the 10% dextrose peritoneal solution (or 4.25% standard PD solution) prior to the planned two hour drain.
Measured: Two hours
Secondary outcomes (1)
Comparison of total sodium removed compared to baseline
This exploratory efficacy outcome will be addressed by comparing the quantity of sodium removed during the two-hour dwell between the two solutions
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start1 Dec 2018
- Primary completion1 May 2019
- Study completion31 May 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 Potential Applications for 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Testani, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801226
- Sponsor's protocol ID
- 2000023570
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2018
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rao VS, Turner JM, Griffin M, Mahoney D, Asher J, Jeon S, Yoo PS, Boutagy N, Feher A, Sinusas A, Wilson FP, Finkelstein F, Testani JM. First-in-Human Experience With Peritoneal Direct Sodium Removal Using a Zero-Sodium Solution: A New Candidate Therapy for Volume Overload. Circulation. 2020 Mar 31;141(13):1043-1053. doi: 10.1161/CIRCULATIONAHA.119.043062. Epub 2020 Jan 8.
PubMed 31910658
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study
- ClinicalTrials.gov ID
- NCT03801226
- Acronym / sponsor ID
- 2000023570
- Keywords
- Peritoneal dialysis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 11 Jan 2019 (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 following pilot study will be undertaken to determine the effects of use of a zero-sodium peritoneal dialysate solution (10% dextrose in sterile water) on sodium removal as compared to a standard peritoneal dialysis solution.
Detailed description
While heart failure (HF) is generally regarded as the inability of the heart to pump sufficient blood, on a population level, volume overload is the primary driver of morbidity and hospitalization. The signs and symptoms of volume overload are driven by water accumulation, which is initially driven by sodium retention. This overall goal of this study is to investigate the ability to remove sodium through use of a zero-sodium solution in peritoneal dialysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10% dextrose in sterile water | Experimental | Drug: Two-hour dwell with 10% dextrose in sterile water, Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% DextrosePatients randomized to this arm will undergo a two-hour dwell with 10% dextrose in sterile water at their first visit and Dianeal Low-Calcium with 4.25% Dextrose at their second visit. |
| Dianeal Low-Calcium with 4.25% Dextrose | Active comparator | Drug: Two-hour dwell with 10% dextrose in sterile water, Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% DextrosePatients randomized to this arm will undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first visit and 10% dextrose in sterile water at their second visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients actively undergoing peritoneal dialysis (PD) with a functioning PD catheter
- PD vintage < 3 years
- As judged by treating nephrologist to be at or above optimal volume status (i.e., not dehydrated)
Key exclusion criteria (8 listed)
- Uncontrolled diabetes with frequent episodes of severe hyperglycemia
- Systolic blood pressure < 100 mmHg
- Serum sodium < 130 mEq/L
- 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
- Anemia with hemoglobin <8 g/dL
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 |
|---|---|---|
| Two-hour dwell with 10% dextrose in sterile waterPatients will be randomized to undergo a two-hour dwell with 10% dextrose in sterile water at their first or second study visit and will receive the alternate intervention at the other study visit. | Drug | 10% dextrose in sterile water, Dianeal Low-Calcium with 4.25% Dextrose |
| Two-hour dwell with Dianeal Low-Calcium with 4.25% DextrosePatients will be randomized to undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first or second study visit and will receive the alternate intervention at the other study visit. | Drug | 10% dextrose in sterile water, Dianeal Low-Calcium with 4.25% Dextrose |
Primary outcome
Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event
Time frame: Two hours
Protocol discontinuation will be defined by premature draining of the 10% dextrose peritoneal solution (or 4.25% standard PD solution) prior to the planned two hour drain.
1 secondary outcome
Comparison of total sodium removed compared to baseline
Time frame: Two hours
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 18 Dec 2019.
- Derived from this study: PubMed 31910658Rao VS, Turner JM, Griffin M, Mahoney D, Asher J, Jeon S, Yoo PS, Boutagy N, Feher A, Sinusas A, Wilson FP, Finkelstein F, Testani JM. First-in-Human Experience With Peritoneal Direct Sodium Removal Using a Zero-Sodium Solution: A New Candidate Therapy for Volume Overload. Circulation. 2020 Mar 31;141(13):1043-1053. doi: 10.1161/CIRCULATIONAHA.119.043062. Epub 2020 Jan 8.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Two-hour dwell with 10% dextrose in sterile water and Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose in people with Potential Applications for Heart Failure and Volume Overload, 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 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: finished, as of the sponsor's last update on 18 Dec 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event (time frame: Two hours). 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 NCT03801226, 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 18 Dec 2019.