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New treatment option for Peritoneal Dialysis, Heart Failure
Official title Exploring Water-free Sodium Storage
ClinicalTrials.gov ID: NCT06872645
What this study is testing
What is 5% Dextrose/Water?
5% Dextrose/Water is an investigational medicine, being studied as a potential treatment for peritoneal dialysis, heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.