Clinical trial NCT05128188: SASH: Sodium Accumulation Study In Haemodialysis
Official title: Sodium Accumulation Study In Haemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemodialysis
End Stage Renal Disease on Dialysis
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 10
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 5 participants will be recruited from the renal unit

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Ascertainment of MRI measures of skin sodium content in 100% of patients studied
timeFrame: 6 months
measure: Ascertainment of MRI measures of muscle sodium content in 100% of patients studied
timeFrame: 6 months
Secondary outcomes:
measure: To study skin sodium in haemodialysis patients and compare with previously reported healthy normal values
timeFrame: 6 months
measure: To study muscle sodium in haemodialysis patients and compare with previously reported healthy normal values
timeFrame: 6 months
measure: To measure degree of change in skin sodium content in relation to a single haemodialysis treatment
timeFrame: 6 months
measure: To measure degree of change in muscle sodium content in relation to a single haemodialysis treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: University Hospitals of Derby and Burton NHS Foundation Trust
Study officials:
affiliation: University Hospitals of Derby and Burton NHS Foundation Trust
name: Nicholas Selby, Professor
role: PRINCIPAL_INVESTIGATOR
References: