SASH: Sodium Accumulation Study In Haemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-09-02

Brief Summary

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Haemodialysis (HD) sustains life in patients with end-stage kidney disease (ESKD) but is associated with a marked increase in incidence of cardiovascular disease (CVD) and high annual mortality rates. The pathogenesis of CVD in patients on HD is multifactorial and complex but hypertension is thought to be a major contributing factor. Sodium balance is normally regulated by the kidneys in health but has to be achieved by sodium removal during HD for those with ESKD. Recent evidence suggests that accumulation of sodium in the skin and / or muscle may be a critical factor impacting the development of hypertension and CVD in patients with ESKD and non-invasive methods are therefore required to study tissue sodium accumulation in this context. This study aims to determine the change in skin and muscle sodium content in patients undergoing haemodialysis. Participants will have a single haemodialysis session, and undergo two MRI scans (one prior to and one following dialysis).

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Detailed Description

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It has been proposed that tissue sodium accumulation in skin and/or muscle is a key factor in hypertension. 23Na MRI allows the assessment of skin and muscle sodium storage and will therefore be a valuable tool in elucidating the role of tissue sodium accumulation in the pathogenesis of salt-sensitive hypertension and cardiovascular morbidity and mortality. Moreover, if haemodialysis in patients with end-stage kidney disease (ESKD) results in changes in tissue sodium, the development of 23Na skin and muscle measures would allow for a method to correlate skin tissue sodium content with detailed cardiovascular and functional assessments.

Participants will have a single haemodialysis session, and undergo two MRI scans (one prior to and one following dialysis), in conjunction with clinical data collection (eg. blood samples, bioimpedance analysis, skin autoflorescence).

Conditions

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Haemodialysis End Stage Renal Disease on Dialysis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients on haemodialysis

5 patients on haemodialysis will be recruited. The study involves a single dialysis session and two MRI scans (one prior and one following dialysis) and collection of clinical data.

No intervention will be given in this study

Intervention Type OTHER

No intervention will be given in this study

Interventions

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No intervention will be given in this study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 50-75 years inclusive
* Male 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

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No