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NCT02212327 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
41
Enrollment target

NCT02212327 is a clinical trial that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 41 participants.

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The verdict

NCT02212327 has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
41 participants
Enrollment target

Study 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.

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2014-08
Est. Completion 2016-11-29

What the Registry Record Tells You About NCT02212327

The ClinicalTrials.gov registry entry for NCT02212327 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT02212327 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02212327 about?

NCT02212327 is a clinical study titled "Testing Tissue Sodium Stores in CAPD Patients-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 su...

What is the current status of trial NCT02212327?

This trial is currently completed. The enrollment target is 41 participants. The study started on 2014-08. Estimated completion is 2016-11-29.

Who is sponsoring clinical trial NCT02212327?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

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