Exploring Water-free Sodium Storage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-03

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peritoneal Dialysis, Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, blinded crossover study

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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5% dextrose peritoneal dialysis, 2-hour dwell

Individuals will receive up to 2 liters of 5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days

Group Type EXPERIMENTAL

5% Dextrose/Water

Intervention Type DRUG

Patients will be randomized to undergo up to two-hour dwell with 5% dextrose in sterile water for 5 days

1.5% dextrose peritoneal dialysis, 2-hour dwell

Individuals will receive up to 2 liters of 1.5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days

Group Type ACTIVE_COMPARATOR

1.5% standard PD fluid

Intervention Type DRUG

Patients will be randomized to undergo up to two-hour dwell with 1.5% standard PD fluid for 5 days

Interventions

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5% Dextrose/Water

Patients will be randomized to undergo up to two-hour dwell with 5% dextrose in sterile water for 5 days

Intervention Type DRUG

1.5% standard PD fluid

Patients will be randomized to undergo up to two-hour dwell with 1.5% standard PD fluid for 5 days

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No