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NCT Number: NCT05128188

SASH: Sodium Accumulation Study In Haemodialysis

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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Key information

Conditions

Haemodialysis End Stage Renal Disease on Dialysis

Age range

50 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, DE22 3NE, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention will be given in this study

Other

No intervention will be given in this study

Primary outcomes

  1. Ascertainment of MRI measures of skin sodium content in 100% of patients studied

    Time frame: 6 months

    Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques.

  2. Ascertainment of MRI measures of muscle sodium content in 100% of patients studied

    Time frame: 6 months

    Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques.

Secondary outcomes

  1. To study skin sodium in haemodialysis patients and compare with previously reported healthy normal values

    Time frame: 6 months

    Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques

  2. To study muscle sodium in haemodialysis patients and compare with previously reported healthy normal values

    Time frame: 6 months

    Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques

  3. To measure degree of change in skin sodium content in relation to a single haemodialysis treatment

    Time frame: 6 months

    Quantification of sodium in skin and muscle and compare finding before and after dialysis

  4. To measure degree of change in muscle sodium content in relation to a single haemodialysis treatment

    Time frame: 6 months

    Quantification of sodium in skin and muscle and compare finding before and after dialysis

Sponsors and collaborators

Lead sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Other

Registry information

Official study title

Sodium Accumulation Study In Haemodialysis

Acronym: SASH

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2021
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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