CompletedEarly Phase 1

Zero Sodium Peritoneal Dialysate Protocol Pilot Study

United States12 participantsStarted 2018-12-01

Plain-language summary

The following pilot study will be undertaken to determine the effects of use of a zero-sodium peritoneal dialysate solution (10% dextrose in sterile water) on sodium removal as compared to a standard peritoneal dialysis solution.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients actively undergoing peritoneal dialysis (PD) with a functioning PD catheter
. PD vintage \< 3 years
. As judged by treating nephrologist to be at or above optimal volume status (i.e., not dehydrated)

Exclusion criteria

. Uncontrolled diabetes with frequent episodes of severe hyperglycemia
. Systolic blood pressure \< 100 mmHg
. Serum sodium \< 130 mEq/L
. 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
. Anemia with hemoglobin \<8 g/dL
. Serum bicarbinate \< 18 mEq/L
. Anuric renal failure
. Inability to give written informed consent or follow study protocol

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event

Timeframe: Two hours

Trial details

NCT IDNCT03801226

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-01

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