Zero Sodium Peritoneal Dialysate Protocol Pilot Study

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03801226
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Potential Applications for Heart Failure; Volume Overload	Drug: Two-hour dwell with 10% dextrose in sterile water; Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose	Early Phase 1

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

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study
• Actual Study Start Date: Dec 1, 2018
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 10% dextrose in sterile water 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.	Drug: Two-hour dwell with 10% dextrose in sterile water; 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.; Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose; 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.
Active Comparator: Dianeal Low-Calcium with 4.25% Dextrose 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.	Drug: Two-hour dwell with 10% dextrose in sterile water; 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.; Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose; 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.

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event [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.

Secondary Outcome Measures

1. Comparison of total sodium removed compared to baseline [Two hours]

   This exploratory efficacy outcome will be addressed by comparing the quantity of sodium removed during the two-hour dwell between the two solutions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients actively undergoing peritoneal dialysis (PD) with a functioning PD catheter

2. PD vintage < 3 years

3. As judged by treating nephrologist to be at or above optimal volume status (i.e., not dehydrated)

Exclusion Criteria:

1. Uncontrolled diabetes with frequent episodes of severe hyperglycemia

2. Systolic blood pressure < 100 mmHg

3. Serum sodium < 130 mEq/L

4. 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter

5. Anemia with hemoglobin <8 g/dL

6. Serum bicarbinate < 18 mEq/L

7. Anuric renal failure

8. Inability to give written informed consent or follow study protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Yale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeffrey Testani, Associate Professor of Medicine, Yale University
• ClinicalTrials.gov Identifier: NCT03801226
• Other Study ID Numbers: 2000023570
• First Posted: Jan 11, 2019
• Last Update Posted: Dec 18, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jeffrey Testani, Associate Professor of Medicine, Yale University: Peritoneal dialysis
• Additional relevant MeSH terms: Heart Failure; Calcium

Study Results

No Results Posted as of Dec 18, 2019