Zero Sodium Peritoneal Dialysate Protocol Pilot Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:December 1, 2018
End Date:December 31, 2020
Contact:Devin D Mahoney
Email:devin.mahoney@yale.edu
Phone:203-737-6227

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Zero Sodium Peritoneal Dialysate Protocol in Human 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.

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.

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
We found this trial at
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New Haven, Connecticut 6520
(203) 432-4771
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