Testing Tissue Sodium Stores in CAPD Patients-Aims 1 & 2
Public ClinicalTrials.gov record NCT02212327. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02212327
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 41 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2014
- Primary completion
- Nov 28, 2016
- Completion
- Nov 28, 2016
- Last update posted
- Oct 2, 2019
2014 – 2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02212327, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2019 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02212327 live on ClinicalTrials.gov.