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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10% dextrose in sterile water | Experimental | 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. |
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| Dianeal Low-Calcium with 4.25% Dextrose | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two-hour dwell with 10% dextrose in sterile water | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31910658 | Derived | 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. |
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| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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| Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose | Drug | 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. |
|