Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT06872645

Conditions

Peritoneal Dialysis, Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

5% Dextrose/Water

1.5% standard PD fluid

Study Details

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.

Conditions

Peritoneal Dialysis, Heart Failure

Study ID

NCT06872645

Start date

Oct 3, 2025

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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

active comparator: 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

Interventions

5% Dextrose/Water

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

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

Primary outcome measure

  • Water free Na removal over the 5-day intervention [ Time Frame: Daily for 5 days ]

Central Contacts and Locations

Central contacts

Veena Rao, PhD

2037857917veena.s.rao@yale.edu

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Veena Rao, PhD

203-785-7917veena.s.rao@yale.edu

Principal Investigator:

Jeffrey Testani, MD

More Information

Sponsor

Yale University

Last update posted

May 13, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Yale University on 2026-05-13.