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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02212327
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Alp Ikizler, Vanderbilt University Medical Center

Tracking Information
First Submitted Date August 6, 2014
First Posted Date August 8, 2014
Last Update Posted Date October 3, 2019
Study Start Date August 2014
Actual Primary Completion Date November 29, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2014)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Testing Tissue Sodium Stores in CAPD Patients—Aims 1 & 2
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

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood and urine samples
Sampling Method Probability Sample
Study Population Patients on PD and healthy controls
Condition End Stage Renal Disease
Intervention Not Provided
Study Groups/Cohorts
  • PD subjects
  • Controls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 2, 2019)
41
Original Estimated Enrollment
 (submitted: August 7, 2014)
60
Actual Study Completion Date November 29, 2016
Actual Primary Completion Date November 29, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02212327
Other Study ID Numbers 140157
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alp Ikizler, Vanderbilt University Medical Center
Study Sponsor Vanderbilt University Medical Center
Collaborators Baxter Healthcare Corporation
Investigators
Principal Investigator: Alp Ikizler, MD Vanderbilt University
Principal Investigator: Jens Titze, MD Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date October 2019