SASH: Sodium Accumulation Study In Haemodialysis (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).

Study Overview

• Status: Not yet recruiting
• Conditions: Haemodialysis; End Stage Renal Disease on Dialysis
• Intervention / Treatment: Other: No intervention will be given in this study

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).

• Study Type: Observational
• Enrollment (Anticipated): 5

Contacts and Locations

• Study Contact: Name: Rebecca Noble, Dr; Phone Number: 01332340131; Email: mszran@exmail.nottingham.ac.uk

Study Locations

• United Kingdom
  • Derby, United Kingdom, DE22 3NE
    • University Hospitals of Derby and Burton NHS Foundation Trust
    • Contact: Nicholas Selby, Professor; Email: nicholas.selby@nottingham.ac.uk
    • Contact: Rebecca Noble, Dr; Email: Rebecca.Noble1@nottingham.ac.uk
    • Principal Investigator: Nicholas Selby, Professor
    • Sub-Investigator: Maarten Taal, Professor
    • Sub-Investigator: Sue Francis, Professor
    • Sub-Investigator: Ben Prestwich, Mr
    • Sub-Investigator: Rebecca Noble, Dr
    • Sub-Investigator: Kelly White, Miss

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

5 participants will be recruited from the renal unit

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No intervention will be given in this study; No intervention will be given in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ascertainment of MRI measures of skin and muscle sodium content in 100% of patients studied	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study skin and muscle sodium in haemodialysis patients and compare with previously reported healthy normal values	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	6 months
To measure degree of change in skin and muscle sodium content in relation to a single haemodialysis treatment	Quantification of sodium in skin and muscle and compare finding before and after dialysis	6 months
To determine associations between skin and muscle sodium content and blood pressure, and change in skin and muscle sodium content with ultrafiltration volume and plasma-dialysate sodium gradient	By clinical data collection before, during and after dialysis	6 months
To determine associations between skin and muscle sodium content and cardiac function as determined by left ventricular mass (LVM) pressure	MRI abdominal coil will be used to collect cardiac MRI scans	6 months

Collaborators and Investigators

• Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
• Investigators: Principal Investigator: Nicholas Selby, Professor, University Hospitals of Derby and Burton NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2022
• Primary Completion (Anticipated): May 15, 2022
• Study Completion (Anticipated): June 15, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: UHDB/2021/020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No