NCT05966116 Sodium Accumulation Study in Haemodialysis: Brain Study
| NCT ID | NCT05966116 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospitals of Derby and Burton NHS Foundation Trust |
| Condition | Dialysis; Complications |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-07-18 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2024-07-18 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Rebecca A Noble, BMBS
PRINCIPAL INVESTIGATOR
The University of Nottingham
Frequently Asked Questions
Who can join the NCT05966116 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 75 Years, studying Dialysis; Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05966116 currently recruiting?
Yes, NCT05966116 is actively recruiting participants. Contact the research team at rebecca.noble1@nottingham.ac.uk for enrollment information.
Where is the NCT05966116 trial being conducted?
This trial is being conducted at Derby, United Kingdom.
Who is sponsoring the NCT05966116 clinical trial?
NCT05966116 is sponsored by University Hospitals of Derby and Burton NHS Foundation Trust. The principal investigator is Rebecca A Noble, BMBS at The University of Nottingham. The trial plans to enroll 10 participants.