Sodium Deposition in Soft Tissues of Patients with Kidney Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorChris McIntyre

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant, breastfeeding or intending pregnancy

Unable to give consent or understand written information

Contraindication to MRI study

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Measuring sodium content

    Other intervention

    Sodium MRI measurement of sodium content in the tissues of all participants

Treatment groups

400 Participants
are divided into 5 treatment groups
Group A: Chronic hemodialysis patients1 intervention
Group B: Peritoneal dialysis patients1 intervention
Group C: Adult and paediatric patients with CKD stage 1-51 intervention
Group D: Healthy adult and paediatric controls1 intervention
Group E: Heart failure patients with and without renal dysfunction1 intervention

Trial outcomes

Primary outcomes

1

Na content in the skin, muscle and skeleton of five cohorts

Time frame
2 years

Secondary outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chris McIntyre

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor institution