Zero Sodium Peritoneal Dialysate Protocol Pilot Study

Completed · Early Phase 1

Conditions studied: Potential Applications for Heart Failure, Volume Overload

In brief

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.

Key facts

Study ID

NCT03801226

Run by

Yale University

People needed

12

Starts

2018-12-01

Expected to finish

2019-05-31

Last updated by the study team

2019-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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