Sodium Accumulation Study in Haemodialysis: Brain Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-75
SponsorUniversity Hospitals of Derby and Burton NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Active infection or malignancy

Amputee

Pregnancy

Contraindication to MRI scanning including claustrophobia, pacemaker, metallic implants etc

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Proportion of brain images that can be analysed for sodium levels

success criterion \> 85%

Time frame
12 months

Secondary outcomes

1

Change in grey and white matter sodium levels

comparing before and after dialysis

Time frame
12 months
2

Association between change in brain sodium levels to proton MRI measures

grey/white matter volume, T1

Time frame
12 months

Other outcomes

Sponsors and contacts

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