Peritoneal Dialysis, Heart Failure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUG5% Dextrose/Water
Patients will be randomized to undergo up to two-hour dwell with 5% dextrose in sterile water for 5 days
DRUG1.5% standard PD fluid
Patients will be randomized to undergo up to two-hour dwell with 1.5% standard PD fluid for 5 days
Sponsors
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized, blinded crossover study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ESRD Patients actively undergoing PD with a reliably functioning PD catheter * Systolic blood pressure \> 130 mmHg * Serum sodium \>135 mmol/L * daily urine output \< 400ml * stable PD prescription for at least 2 months without requirement of 4.25% glucose PD solution * PD vintage of at least 6 months * Euvolemic as defined by the patient at their dry weight and free of any signs or symptoms of volume overload, per referring nephrologist
Exclusion criteria
* Poorly controlled diabetes with hemoglobin A1C\>9% * 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter * Anemia with hemoglobin \<8g/dL * Inability to give written informed consent or follow study protocol. * Urinary incontinence * Body weight \< 60kg * gastrointestinal disease that causes diarrhea or expectation of sodium losses in stool. * use of amiodarone in the last 6 months (which will interfere with tissue iodine ascertainment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Water free Na removal over the 5-day intervention | Daily for 5 days | 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 |
Countries
United States
Contacts
CONTACTVeena Rao, PhD
PRINCIPAL_INVESTIGATORJeffrey Testani, MD
Yale University
Outcome results
None listed