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Sponsor study identifier
observational
41
1 country
1
Study Start
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 29, 2016
Actual (reported)Study Completion
November 29, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 29, 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
August 6, 2014
Actual (reported)August 8, 2014
Actual (reported)November 29, 2016
Actual (reported)November 29, 2016
Actual (reported)Aim 1: Na+ stores in PD subjects vs. controls
baseline
Aim 2: a change in Na+ stores in PD subjects
baseline and 2 years
Patients on PD and healthy controls
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
blood and urine samples
Alp Ikizler, MD
Vanderbilt University
Jens Titze, MD
Vanderbilt University
41 participants (actual enrollment reported by the registry).
First Submitted
August 6, 2014
First Posted
August 8, 2014
Study Start
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
November 29, 2016
Actual (reported)Study Completion
November 29, 2016
Actual (reported)Last Updated
October 3, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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