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Sodium Deposition in Soft Tissues of Patients With Kidney Disease

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ClinicalTrials.gov Identifier: NCT03004547
Recruitment Status : Recruiting
First Posted : December 29, 2016
Last Update Posted : December 22, 2022
Sponsor:
Information provided by (Responsible Party):
Chris McIntyre, Lawson Health Research Institute

Study Description
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Brief Summary:
Sodium (Na+) hemostasis is abnormal in CKD patients, and this element can be deposited in the skin, muscle, and skeleton - to cope with long term sodium loading. It is known that sodium stored in this non-osmotically active way, is profoundly inflammatory. Furthermore, inflammation has been associated with several uremic symptoms. The investigators will use novel Na+ MRI imaging to examine the Na+ deposition in the skin, muscle, and skeleton of five groups:1) chronic in-center hemodialysis patients, 2) chronic peritoneal dialysis patients, 3) adult and paediatric patients with CKD stage 1-5 and 4) heart failure patients with and without renal dysfunction 5) sex and age-matched healthy adult and paediatric controls. Additionally, they will investigate the association between sodium deposition in these tissues with uremic symptomatology and biochemical markers of metabolism.

Condition or disease Intervention/treatment
Haemodialysis Complication Other: Measuring sodium content

Detailed Description:

Kidneys have a key role in sodium hemostasis through their excretory function. In patients with chronic kidney disease (CKD), kidney function is impaired; thus, suggesting that sodium handling is abnormal in this setting with long-term sodium loading (from oral intake) and lack of adequate urinary excretion. Yet, sodium concentration needs to stay relatively constant to prevent fatal intra-cellular accumulation, which would result in cell injury and death. In hemodialysis patients, at least a part of this extra sodium is non-osmotically active and deposited in the skin, muscle, and skeleton.

Furthermore, it has become increasingly recognized that sodium (once accumulated in tissues) is directly pro-inflammatory, affecting the innate immune system by regulating the activity of macrophages in skin. This linkage between sodium and inflammation indicates a potential link between sodium deposition and uremic symptoms experienced by patients.

There have been no studies to date examining the sodium deposition in the skin, muscle, and skeleton of patients with different kidney function and renal replacement therapy.

This is a pilot study involving a single center recruiting patients from the prevalent maintenance hemodialysis, peritoneal dialysis , CKD stage 1-5, and heart failure populations of London, Ontario, compared to healthy controls. Once recruited, participants will undergo one study visit with the potential of up to two follow-up visits (on a non-dialysis day for hemodialysis patients). Participants will be followed for up to two years after the first study visit. Each session will include symptom questionnaires, the five times sit to stand and 60-second chair stand test (excluding all children), blood pressure and heart rate measurements, blood work (excluding healthy children and adolescents), urine sampling (excluding those on dialysis), an echocardiogram (excluding healthy controls), and an MRI scan of the lower leg detecting sodium content.

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Sodium Deposition in Soft Tissues of Patients With Kidney Disease and Its Association With Patient Symptomatology
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Groups and Cohorts
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Group/Cohort Intervention/treatment
Chronic hemodialysis patients
Patients on standard in-centre 3 times a week hemodialysis
 Other: Measuring sodium content
Sodium MRI measurement of sodium content in the tissues of all participants
Peritoneal dialysis patients
Patients on peritoneal dialysis
 Other: Measuring sodium content
Sodium MRI measurement of sodium content in the tissues of all participants
Adult and paediatric patients with CKD stage 1-5
Patients with chronic kidney disease stage 1-5 (not dialysis dependent)
 Other: Measuring sodium content
Sodium MRI measurement of sodium content in the tissues of all participants
Healthy adult and paediatric controls
Subjects without kidney disease
 Other: Measuring sodium content
Sodium MRI measurement of sodium content in the tissues of all participants
Heart failure patients with and without renal dysfunction
Heart failure patients (atrial fibrillation etc ...) with and without renal dysfunction
 Other: Measuring sodium content
Sodium MRI measurement of sodium content in the tissues of all participants


Outcome Measures
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Primary Outcome Measures :
  1. Na content in the skin, muscle and skeleton of five cohorts [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Inflammatory Marker: CRP levels [ Time Frame: 2 years ]
  2. Uremic symptom scores among the different groups [ Time Frame: 2 years ]
  3. Liver function markers [ Time Frame: 2 years ]
  4. Liver damage markers (liver enzymes) [ Time Frame: 2 years ]
  5. cardiac markers (troponin) [ Time Frame: 2 years ]
  6. bone markers (ALP, vitamin D levels) [ Time Frame: 2 years ]
  7. Uremic toxin levels [ Time Frame: 3-4 years ]
  8. Endotoxin levels [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA

We will measure complete blood count, urea and electrolytes, magnesium, calcium, phosphate, liver function tests, clotting markers, cardiac biomarkers (Troponin T), 25-hydroxyVitamin D and 1,25-dihydroxyVitamin D, CRP, glucose, intact PTH, creatinine, cystatin C, and lactate.

A portion of this blood sample will be sent to the laboratory on-site and the remaining portion will be for processed on-site and stored in the Kidney Clinical Research Unit, LHSC until the end of the study when endotoxin and uremic toxin measurement will be performed.


Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We will recruit up to 400 participants; approximately 125 dialysis patients including 50 children/adolescents on dialysis, 200 patients with various stages of chronic kidney disease including heart failure patients and approximately 25 children/adolescents with chronic kidney disease, and 75 individuals with no kidney disease including approximately 25 healthy children/adolescents.
Criteria

Inclusion Criteria:

  • Age greater than or equal to 6 years
  • For patients on maintenance hemodialysis or peritoneal dialysis: more than 3 months duration of therapy
  • For patients with CKD stage 1-5: CKD stage 1-5 and no indications to start dialysis
  • For heart failure patients: with or without renal dysfunction
  • For healthy controls: lack of kidney disease, heart failure, liver cirrhosis, and peripheral edema

For subsequent visits (must meet 1 of the below indicators):

  • Change in dialysis prescription
  • Change in renal replacement therapy modality
  • Change in medication
  • Parathyroidectomy
  • Intervention added to or removed from dialysis (i.e. such as but not limited exercise, cooling, and ischemic preconditioning)

Exclusion Criteria:

  • Pregnant, breastfeeding or intending pregnancy
  • Unable to give consent or understand written information
  • Contraindication to MRI study
Contacts and Locations
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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): NCT03004547


Contacts
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Contact: Christopher W McIntyre, PhD, MD 519-685-8500 ext 58502 christopher.mcintyre@lhsc.on.ca
Contact: Alireza Akbari, PhD aakbari@uwo.ca

Locations
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Canada, Ontario
LHSC Regional Renal Care Program Recruiting
London, Ontario, Canada
Contact: Christopher W McIntyre, MD, PhD    519-685-8500 ext 58502    christopher.mcintyre@lhsc.on.cas   
Sub-Investigator: Alireza Akbari, PhD         
Sub-Investigator: Guido Filler, MD         
Sub-Investigator: Jean Theberge, PhD         
Sub-Investigator: Timothy Scholl, PhD         
Sponsors and Collaborators
Chris McIntyre
Investigators
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Principal Investigator: Christopher W McIntyre, PhD, MD Western University, Canada
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chris McIntyre, Professor of Medicine, UWO, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03004547    
Other Study ID Numbers: 108765
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chris McIntyre, Lawson Health Research Institute:
Sodium
Soft Tissues
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases