Trials Sponsors Conditions Drugs Pricing

Conditions

Peritoneal Dialysis, Heart Failure

Outcome Measures

Primary Outcomes (1)

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

Other Outcomes (1)

Change in total extracellular Na and osms
Day 1 and day 5

Study Arms (2)

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

Drug: 5% Dextrose/Water

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

Drug: 1.5% standard PD fluid

Interventions

5% Dextrose/WaterDrug

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

5% dextrose peritoneal dialysis, 2-hour dwell

1.5% standard PD fluidDrug

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

1.5% dextrose peritoneal dialysis, 2-hour dwell

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

ESRD Patients actively undergoing PD with a reliably functioning PD catheter
Systolic blood pressure \> 130 mmHg

Sponsors & Collaborators

Yale University
Otherlead
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIHcollaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

Veena Rao, PhDCONTACT203-785-7917 veena.s.rao@yale.edu

Jeffrey Testani, MDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Heart Failure

Interventions

GlucoseWater

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesHydroxidesAlkaliesInorganic ChemicalsAnions

Study Officials

Jeffrey Testani, MD
Yale University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Veena Rao, PhD

CONTACT

2037857917 veena.s.rao@yale.edu

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 12, 2025

Study Start

October 3, 2025

Actual (reported)

Primary Completion

June 30, 2028

Exploring Water-free Sodium Storage

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

5% dextrose peritoneal dialysis, 2-hour dwell

1.5% dextrose peritoneal dialysis, 2-hour dwell

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

5% dextrose peritoneal dialysis, 2-hour dwell

1.5% dextrose peritoneal dialysis, 2-hour dwell

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations