Testing Tissue Sodium Stores in CAPD Patients—Aims 1 & 2

End Stage Renal Disease Clinical Trial

Official title:

Testing Tissue Sodium Stores in Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients Receiving Icodextrin or Glucose-Based Dialysate, A Randomized Trial—Aims 1 & 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212327
• Other study ID #: 140157
• Status: Completed
• Start date: August 2014
• Est. completion date: November 29, 2016

Study information

• Verified date: October 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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). Volume regulation in PD patients is related to hypertension, heart failure, nutritional status, and survival. Salt (NaCl) is the body's ion transport target to normally regulate volume via the kidneys; however, in hemodialysis (HD) patients the dialyser or in PD patients the peritoneal membrane, must serve that purpose. Determining volume status in PD patients is not easy and monitoring sodium (Na+) is more difficult still. The investigators have developed a novel, noninvasive approach to this problem involving 23Na+ magnetic resonance imaging (Na-MRI). Na+ is stored bound to proteoglycans in mostly the skin. Our technique measures Na+ in skin and skeletal muscle. In this study, we propose to apply this novel technique to PD patients.

Aim 1. To determine Na+ stores in PD patients, to compare Na+ stores to normal controls using Na-MRI technique, and to correlate Na+ stores by Na-MRI with multifrequency bioimpedance measurements and cross-sectional clinical data.

Hypothesis: Na+ stores are increased in PD patients compared to normal controls; they are increased in PD patients with volume expansion and in those patients with high soluble vascular endothelial growth factor receptor-3 (sFlt-4) levels.

Aim 2. To determine the utility of Na-MRI as an assessment of preserving residual renal function in PD patients.

Hypothesis: Extracellular volume expansion as measured by multifrequency bioimpedance was found to have no utility in predicting preservation of residual renal function in PD patients. The investigators hypothesize that Na+ stores as determined by 23Na-MRI will fulfill that function and will be inversely, rather than directly, related.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 29, 2016
• Est. primary completion date: November 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aim 1: Na+ stores in PD subjects vs. controls		baseline
Primary	Aim 2: a change in Na+ stores in PD subjects		baseline and 2 years