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NCT Number: NCT06872645

Exploring Water-free Sodium Storage

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06510, United States

Location status: Recruiting

Location contact

Jeffrey Testani, MD

PRINCIPAL_INVESTIGATOR

Veena Rao, PhD

CONTACT

[email protected]

203-785-7917

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

5% Dextrose/Water

Drug

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

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

Primary outcomes

  1. Water free Na removal over the 5-day intervention

    Time frame: 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

Other outcomes

  1. Change in total extracellular Na and osms

    Time frame: Day 1 and day 5

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Veena Rao, PhD

CONTACT

[email protected]

2037857917

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: NOS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 12, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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