Zero Sodium Peritoneal Dialysate Protocol Pilot Study

Volume Overload Clinical Trial

Official title:

Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801226
• Other study ID #: 2000023570
• Status: Completed
• Phase: Early Phase 1
• Start date: December 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: December 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 31, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Potential Applications for Heart Failure
• Volume Overload

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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