Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.


Condition or disease
End Stage Renal Disease

Layout table for study information
Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Group/Cohort
PD subjects
Controls



Primary Outcome Measures :
  1. Aim 1: Na+ stores in PD subjects vs. controls [ Time Frame: baseline ]
  2. Aim 2: a change in Na+ stores in PD subjects [ Time Frame: baseline and 2 years ]

Biospecimen Retention:   Samples Without DNA
blood and urine samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients on PD and healthy controls
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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Baxter Healthcare Corporation
Investigators
Layout table for investigator information
Principal Investigator: Alp Ikizler, MD Vanderbilt University
Principal Investigator: Jens Titze, MD Vanderbilt University

Layout table for additonal information
Responsible Party: Alp Ikizler, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02212327    
Other Study ID Numbers: 140157
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Keywords provided by Alp Ikizler, Vanderbilt University Medical Center:
Na+ MRI
salt stores
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency