Zero sodium peritoneal dialysate protocol in human pilot study

Trial Purpose and Description

The following pilot study will be undertaken to determine if a consistent sodium removal can be obtained with a zero-sodium peritoneal dialysate solution (10% dextrose in sterile water) as compared to a standard 4.25% Dianeal solution with a sodium concentration of 132 meQ/L.

Ages: 18 years and older

Gender: Both


Eligibility Criteria

Inclusion Criteria

1)      Patients actively undergoing PD with a functioning PD catheter

2)      PD vintage < 3 years

3)      Age >18 years of age

4)      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)  SBP <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 <8g/dL

6)  Serum bicarbonate < 18 mEq/L

7)   Anuric renal failure

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


Yale University School of Medicine

Start Date: 11/01/2018

End Date: 06/30/2019

Last Updated: 04/11/2019

Study HIC#: 2000023570

Get Involved

For more information about this study, contact:
Devin Mahoney
+1 203-737-1226
devin.mahoney@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

Jeffrey Testani

Principal Investigator

Sub-Investigators