Testing Tissue Sodium Stores in CAPD Patients—Aims 1 & 2
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|ClinicalTrials.gov Identifier: NCT02212327|
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : October 3, 2019
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.
|Condition or disease|
|End Stage Renal Disease|
|Study Type :||Observational|
|Actual Enrollment :||41 participants|
|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|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||November 29, 2016|
|Actual Study Completion Date :||November 29, 2016|
- Aim 1: Na+ stores in PD subjects vs. controls [ Time Frame: baseline ]
- Aim 2: a change in Na+ stores in PD subjects [ Time Frame: baseline and 2 years ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212327
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Alp Ikizler, MD||Vanderbilt University|
|Principal Investigator:||Jens Titze, MD||Vanderbilt University|