Zero Sodium Peritoneal Dialysate Protocol Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Potential Applications for Heart Failure; Volume Overload
• Intervention / Treatment: Drug: Two-hour dwell with 10% dextrose in sterile water; Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Two hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Two hours

Collaborators and Investigators

• Sponsor: Yale University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Peritoneal dialysis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: 2000023570

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No