Water-Free Sodium Storage Exploration

(NOS Trial)

Overseen By Alexandra Radel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Amiodarone

Disqualifiers: Diabetes, Anemia, Incontinence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the body stores sodium without water, which could clarify its health impact. Researchers use two types of dextrose solutions in peritoneal dialysis (a treatment for kidney failure) to examine sodium storage and release. Individuals with end-stage kidney disease who already use peritoneal dialysis might be suitable candidates. Participants should maintain stable dialysis routines and not require certain glucose solutions. The study aims to determine whether sodium storage locations inside or outside cells affect outcomes. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance future kidney disease treatments.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using amiodarone, you must have stopped it at least 6 months before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that peritoneal dialysis, which uses a sugar solution like dextrose, is safe in various situations. One study reported 34 side effects among 12 patients using this treatment, including infections of the abdomen lining, known as peritonitis. However, these side effects were uncommon, and the treatment is generally well-tolerated.

Peritoneal dialysis has also been safely used in children with sudden kidney problems, showing similar results to other treatments. Monitoring blood sugar levels is important, as long-term use of sugar solutions can cause issues for some patients. Overall, peritoneal dialysis, including the use of dextrose solutions, is considered safe, but like any treatment, it carries risks. Participants should discuss possible side effects with their healthcare provider to make an informed choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative methods for sodium storage in the body without relying on water. This approach could potentially offer new insights into managing fluid balance, particularly for patients undergoing peritoneal dialysis. The trial investigates two different concentrations of dextrose solutions (1.5% and 5%) used in peritoneal dialysis, which could reveal how varying sugar levels in the dialysis fluid affect sodium storage. By understanding these dynamics, the trial could lead to more personalized and effective treatments for patients with kidney issues, improving their overall care and quality of life.

What evidence suggests that this trial's treatments could be effective?

This trial will compare two concentrations of dextrose solutions for peritoneal dialysis: a 1.5% dextrose solution and a 5% dextrose solution. Research has shown that peritoneal dialysis, like the 5% dextrose solution in this trial, can effectively remove sodium from the body. A review of studies found that peritoneal dialysis effectively removes sodium, which is crucial for individuals with kidney problems. While effective, frequent use may harm the abdominal cavity lining. This treatment helps remove excess fluid, improving overall fluid balance. However, solutions with glucose might cause damage over time, so weighing the benefits and risks is important. ^{3 6 7 8 9}

Who Is on the Research Team?

Jeffrey Testani, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for ESRD patients on peritoneal dialysis (PD) with stable blood pressure and sodium levels, low daily urine output, and who have been on a consistent PD regimen without the highest glucose solution for at least 2 months. They should be free of volume overload according to their nephrologist.

Inclusion Criteria

My blood pressure is above 130 mmHg.

I produce less than 400ml of urine daily.

I have been on peritoneal dialysis for at least 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 5% dextrose or 1.5% dextrose peritoneal dialysis for 5 days

5 days

Daily visits (inpatient)

Washout

Participants undergo a 6-week washout period before receiving alternate therapy

6 weeks

Alternate Treatment

Participants receive the alternate peritoneal dialysis treatment for 5 days

5 days

Daily visits (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exploring Water-free Sodium Storage

Trial Overview The study aims to determine if water-free sodium can be stored and released in significant amounts, and whether this happens inside or outside cells. It involves comparing two solutions: 5% Dextrose/Water versus standard 1.5% PD fluid in heart failure patients with ascites.

How Is the Trial Designed?

Group I: 5% dextrose peritoneal dialysis, 2-hour dwell Experimental Treatment 1 Intervention

Individuals will receive up to 2 liters of 5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days

Group II: 1.5% dextrose peritoneal dialysis, 2-hour dwell Active Control 1 Intervention

Individuals will receive up to 2 liters of 1.5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. intechopen.com intechopen.com/chapters/50793

Peritoneal Dialysis Solutions PD incorporating a single daily exchange of icodextrin results in significantly higher ultrafiltration, which leads to improvement in volume ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11856993/

Current Progress in Peritoneal Dialysis: A Narrative Review of ... Many reports have discussed the effectiveness of neutralized glucose-based dialysis fluid; however, reports caution against peritoneal damage even with ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468024924015808

Performance Evaluation of an Automated Peritoneal ... In this study, we set out to evaluate the performance of the SGS in prevalent, adult patients with end-stage kidney disease, who are on maintenance PD. We ...

4. researchgate.net researchgate.net/publication/326219576_Sodium_removal_by_peritoneal_dialysis_a_systematic_review_and_meta-analysis

Sodium removal by peritoneal dialysis: a systematic review ... DSR was significantly lower in APD than CAPD [86.2 (57.3-115.1) vs. 141.3 (107.6-174.9) mmol/day, p = 0.015]. Conversely, ultrafiltration (UF) did not differ [ ...

5. mdpi.com mdpi.com/2218-273X/10/5/768

Unfavorable Effects of Peritoneal Dialysis Solutions on the ... One of the main limitations to successful long-term use of peritoneal dialysis (PD) as a renal replacement therapy is the harmful effects of ...

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0030337

Safety Issues of Long-Term Glucose Load in Patients on ... Long-term glucose load predicted mortality and technique failure in chronic PD patients. These findings emphasize the importance of minimizing glucose load in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4693427/

Safety and effectiveness evaluation of a domestic peritoneal ... This study is the first to evaluate the long-term safety and effectiveness of a non-PVC packed peritoneal dialysis fluid.

8. ajkd.org ajkd.org/article/S0272-6386(23)00649-2/fulltext

Updates on Infectious and Other Complications in ... Among patients who initiated PD, the cumulative incidence of conversion to in-center hemodialysis is reported to be approximately 25% at 2 years ...

9. journals.sagepub.com journals.sagepub.com/doi/10.1177/0896860820982120

ISPD guidelines for peritoneal dialysis in acute kidney injury Peritoneal dialysis (PD) for acute kidney injury (AKI) in children has a long track record and shows similar outcomes when compared to ...