Zero Sodium Peritoneal Dialysate Protocol Pilot Study

• Status: Completed
• Trial end date: 2019-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Calcium; Calcium, Dietary; Dialysis Solutions

Criteria

Inclusion Criteria:

1. Patients actively undergoing peritoneal dialysis (PD) with a functioning PD catheter

2. PD vintage < 3 years

3. As judged by treating nephrologist to be at or above optimal volume status (i.e., not dehydrated)

Exclusion Criteria:

1. Uncontrolled diabetes with frequent episodes of severe hyperglycemia

2. Systolic blood pressure < 100 mmHg

3. Serum sodium < 130 mEq/L

4. 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter

5. Anemia with hemoglobin <8 g/dL

6. Serum bicarbinate < 18 mEq/L

7. Anuric renal failure

8. Inability to give written informed consent or follow study protocol