Sodium Deposition in Soft Tissues of Patients with Kidney Disease

NCT03004547 | Recruiting

• 1 other identifier: 108765
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemodialysis Complication

Keywords

Sodium; Soft Tissues

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (8)

• Inflammatory Marker: CRP levels

  2 years

• Uremic symptom scores among the different groups

  2 years

• Liver function markers

  2 years

• Liver damage markers (liver enzymes)

  2 years

• cardiac markers (troponin)

  2 years

Study Arms (5)

Chronic hemodialysis patients

Patients on standard in-centre 3 times a week hemodialysis

Other: Measuring sodium content

Peritoneal dialysis patients

Patients on peritoneal dialysis

Other: Measuring sodium content

Adult and paediatric patients with CKD stage 1-5

Patients with chronic kidney disease stage 1-5 (not dialysis dependent)

Other: Measuring sodium content

Healthy adult and paediatric controls

Subjects without kidney disease

Other: Measuring sodium content

Heart failure patients with and without renal dysfunction

Heart failure patients (atrial fibrillation etc ...) with and without renal dysfunction

Other: Measuring sodium content

Interventions

Measuring sodium content OTHER

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

Adult and paediatric patients with CKD stage 1-5; Chronic hemodialysis patients; Healthy adult and paediatric controls; Heart failure patients with and without renal dysfunction; Peritoneal dialysis patients

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Pregnant, breastfeeding or intending pregnancy
• Unable to give consent or understand written information
• Contraindication to MRI study

Sponsors & Collaborators

• Chris McIntyre: lead

Study Sites (1)

LHSC Regional Renal Care Program

London, Ontario, Canada

RECRUITING

Related Publications (1)

• Lemoine S, Salerno FR, Akbari A, McKelvie RS, McIntyre CW. Tissue Sodium Storage in Patients With Heart Failure: A New Therapeutic Target? Circ Cardiovasc Imaging. 2021 Nov;14(11):e012910. doi: 10.1161/CIRCIMAGING.121.012910. Epub 2021 Nov 16.

  PMID: 34784242 DERIVED

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.

Study Officials

• Christopher W McIntyre, PhD, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher W McIntyre, PhD, MD

CONTACT

519-685-8500; christopher.mcintyre@lhsc.on.ca

Alireza Akbari, PhD

CONTACT

aakbari@uwo.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, UWO

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 29, 2016
• Study Start: March 5, 2018
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)