Back to resultsZero Sodium Peritoneal Dialysate Protocol Pilot Study
Primary Purpose
Potential Applications for Heart Failure, Volume Overload
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Two-hour dwell with 10% dextrose in sterile water
Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose
Sponsored by
About this trial
This is an interventional diagnostic trial for Potential Applications for Heart Failure focused on measuring Peritoneal dialysis
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
10% dextrose in sterile water
Dianeal Low-Calcium with 4.25% Dextrose
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03801226
Brief Title
Zero Sodium Peritoneal Dialysate Protocol Pilot Study
Official Title
Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Potential Applications for Heart Failure, Volume Overload
Keywords
Peritoneal dialysis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10% dextrose in sterile water
Arm Type
Experimental
Arm Description
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.
Arm Title
Dianeal Low-Calcium with 4.25% Dextrose
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Two-hour dwell with 10% dextrose in sterile water
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event
Description
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.
Time Frame
Two hours
Secondary Outcome Measure Information:
Title
Comparison of total sodium removed compared to baseline
Description
This exploratory efficacy outcome will be addressed by comparing the quantity of sodium removed during the two-hour dwell between the two solutions
Time Frame
Two hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31910658
Citation
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.
Results Reference
derived
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Zero Sodium Peritoneal Dialysate Protocol Pilot Study
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