Sodium Deposition in Soft Tissues of Patients with Kidney Disease

February 10, 2025 updated by: Chris McIntyre

Evaluation of Sodium Deposition in Soft Tissues of Patients with Kidney Disease and Its Association with Patient Symptomatology

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • Recruiting
        • LHSC Regional Renal Care Program
        • Contact:
        • Contact:
          • Alireza Akbari, PhD
        • Contact:
          • Guido Filler, MD
        • Contact:
          • Jean Theberge, PhD
        • Contact:
          • Timothy Scholl, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Na content in the skin, muscle and skeleton of five cohorts
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammatory Marker: CRP levels
Time Frame: 2 years
2 years
Uremic symptom scores among the different groups
Time Frame: 2 years
2 years
Liver function markers
Time Frame: 2 years
2 years
Liver damage markers (liver enzymes)
Time Frame: 2 years
2 years
cardiac markers (troponin)
Time Frame: 2 years
2 years
bone markers (ALP, vitamin D levels)
Time Frame: 2 years
2 years
Uremic toxin levels
Time Frame: 3-4 years
3-4 years
Endotoxin levels
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chris McIntyre

Investigators

  • Principal Investigator: Christopher W McIntyre, PhD, MD, Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2018

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

December 16, 2016

First Submitted That Met QC Criteria

December 22, 2016

First Posted (Estimated)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108765

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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