Status:
COMPLETED
Zero Sodium Peritoneal Dialysate Protocol Pilot Study
Lead Sponsor:
Yale University
Conditions:
Potential Applications for Heart Failure
Volume Overload
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
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. Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03801226
Start Date
December 1 2018
End Date
May 31 2019
Last Update
December 18 2019
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06510