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Completed

NCT Number: NCT03801226

Zero Sodium Peritoneal Dialysate Protocol Pilot Study

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.

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Key information

Conditions

Potential Applications for Heart Failure Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms Volume Overload

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Yale University

New Haven, Connecticut, 06510, United States

About this study

While heart failure (HF) is generally regarded as the inability of the heart to pump sufficient blood, on a population level, volume overload is the primary driver of morbidity and hospitalization. The signs and symptoms of volume overload are driven by water accumulation, which is initially driven by sodium retention. This overall goal of this study is to investigate the ability to remove sodium through use of a zero-sodium solution in peritoneal dialysis.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Two-hour dwell with 10% dextrose in sterile water

Drug

Patients will be randomized to undergo a two-hour dwell with 10% dextrose in sterile water at their first or second study visit and will receive the alternate intervention at the other study visit.

Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose

Drug

Patients will be randomized to undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first or second study visit and will receive the alternate intervention at the other study visit.

Primary outcomes

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

    Time frame: Two hours

    Protocol discontinuation will be defined by premature draining of the 10% dextrose peritoneal solution (or 4.25% standard PD solution) prior to the planned two hour drain.

Secondary outcomes

  1. Comparison of total sodium removed compared to baseline

    Time frame: Two hours

    This exploratory efficacy outcome will be addressed by comparing the quantity of sodium removed during the two-hour dwell between the two solutions

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 11, 2019
Registry last updated
Dec 18, 2019

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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