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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK138155 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The overarching goal of this proposal is to definitively establish if acute water free Na storage and release occurs, if the amount stored/released is of a quantity that is physiologically relevant, and if the location is intracellular vs. extracellular.
This study is designed as a an ultra-rigorous inpatient balance study. The main purpose of the study is to determine if significant mobilizable non- extracellular volume (ECV) Na storage occurs in humans. This is a randomized, blinded crossover study. Patients will be randomized to Na free 5% dextrose solution or 1.5% standard peritoneal dialysis (PD) fluid (Dianeal 1.5% low calcium PD solution with standard 132 mmol/L Na and osmolarity of 344 mOsmol/L) and will receive treatment for 5 days, following a 6 week wash out patient will return to undergo 5 days of alternate therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5% dextrose peritoneal dialysis, 2-hour dwell | Experimental | Individuals will receive up to 2 liters of 5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days |
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| 1.5% dextrose peritoneal dialysis, 2-hour dwell | Active Comparator | Individuals will receive up to 2 liters of 1.5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% Dextrose/Water | Drug | Patients will be randomized to undergo up to two-hour dwell with 5% dextrose in sterile water for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Water free Na removal over the 5-day intervention | Water free Na removal will be calculated as [Water Free Na= ((ΔTBW (L) * serum Na (mmol/L)) - Na balance (mmol)]. This will be compared between 5% dextrose Na removal period and 1.5% dextrose standard PD neutral Na balance period | Daily for 5 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in total extracellular Na and osms | Change in total extracellular Na and osms will be calculated as [Change ECV Na = {ECV (L) * serum Na (mmol/L at baseline} - {ECV (L) * serum Na (mmol/L) after dwell). The same approach will be done for osms](streamdown:incomplete-link) | Day 1 and day 5 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veena Rao, PhD | Contact | 2037857917 | veena.s.rao@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Testani, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Recruiting | New Haven | Connecticut | 06510 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D014867 | Water |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D006878 |
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Randomized, blinded crossover study
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| 1.5% standard PD fluid | Drug | Patients will be randomized to undergo up to two-hour dwell with 1.5% standard PD fluid for 5 days |
|
| Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |