Testing Tissue Sodium Stores in CAPD Patients—Aims 1 & 2
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 8/9/2018 |
| Start Date: | August 2014 |
| End Date: | December 2019 |
| Contact: | Alp Ikizler, MD |
| Email: | alp.ikizler@vanderbilt.edu |
| Phone: | 615-343-6104 |
Testing Tissue Sodium Stores in Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients Receiving Icodextrin or Glucose-Based Dialysate, A Randomized Trial—Aims 1 & 2
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.
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.
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.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Alp Ikizler, MD
Phone: 615-343-6225
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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