Status:
COMPLETED
Testing Tissue Sodium Stores in CAPD Patients-Aims 1 & 2
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-80 years
Brief Summary
The investigators' overarching goal is to improve long-term outcomes for end stage renal disease (ESRD) patients. In this study we focus specifically on patients receiving peritoneal dialysis (PD). Vo...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Both subject groups:
- Age 18 to 80 years;
- BMI \< 40;
- Ability to give informed consent;
- Life expectancy greater than 6 months.
- PD subjects:
- On peritoneal dialysis for greater than 3 months;
- Using glucose lactate-buffered PD solutions with consistent glucose exposure;
- Stable peritoneal prescription (Kt/V \> 1.7 or Tccr \> 50 ml/week/1.73 m2).
- Control subjects:
- Estimated glomerular filtration rate (GFR) ≥ 60 ml/min/1.73m2;
- No proteinuria.
- Exclusion Criteria (both subject groups):
- Pregnancy;
- Intolerance to study protocols;
- Severe, unstable, active, or chronic inflammatory disease (congestive heart failure-NY Class IV, active infection, active connective tissue disorder, active cancer or cancer history in the prior 5 years, HIV, liver disease, including active chronic hepatitis B or C);
- Active inflammatory conditions \[systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), minimal change disease (MCD)\];
- Patients prescribed or being treated with spironolactone;
- History of cirrhosis;
- Poor compliance with dialysis prescription.
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 29 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02212327
Start Date
August 1 2014
End Date
November 29 2016
Last Update
October 3 2019
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232