Sodium Accumulation Study in Haemodialysis: Brain Study

NCT05966116 | Recruiting

• 1 other identifier: UHDB/2023/055
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the research study is to look at a new type of MRI scanning that can measure the amount of sodium in different parts of the body. Sodium (or 'salt') levels are very important in maintaining health, and high levels lead to high blood pressure. This is very important to patients with kidney disease, as the kidney is the main organ that regulates the amount of sodium in the body. It is possible to measure blood sodium levels, but this does not tell us how much sodium is present in other areas of the body. Previously, it has not been possible measure this. Sodium MRI (Na-MRI) is a new type of MRI scanning that can directly measure sodium in other parts of body such as skin, muscles, kidneys, and brain. The investigators believe that this will help to guide treatment in patients with kidney disease who are on haemodialysis, research studies are needed to prove the benefits.

Conditions

Dialysis; Complications

Outcome Measures

Primary Outcomes (1)

• Proportion of brain images that can be analysed for sodium levels

  success criterion \> 85%

  12 months

Secondary Outcomes (2)

• Change in grey and white matter sodium levels

  12 months

• Association between change in brain sodium levels to proton MRI measures

  12 months

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 participants (5 male and 5 female) who are over 50 and under 75 years old who have been on haemodialysis for more than 3 months

You may qualify if:

• Age 50-75 years inclusive
• Male and female patients with CKD stage 5 receiving chronic haemodialysis
• Patient has been dialysis dependent for at least 3 months
• Must be able to follow simple instruction in English (on safety ground for MRI scans) and be able to understand the nature and requirements of the study

You may not qualify if:

• Active infection or malignancy
• Amputee
• Pregnancy
• Contraindication to MRI scanning including claustrophobia, pacemaker, metallic implants etc
• Unable or unwilling to provide informed consent
• Medical conditions or overall physical frailty precludes scan session in opinion of investigator
• Any condition which could interfere with the patient's ability to comply with the study

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead
• University of Nottingham: collaborator

Study Sites (1)

Centre for Kidney Research and Innovation

Derby, DE22 3NE, United Kingdom

RECRUITING

Study Officials

• Rebecca A Noble, BMBS

  The University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca A Noble, BMBS

CONTACT

01332340131; rebecca.noble1@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: July 28, 2023
• Study Start: July 18, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

GB (1)