SASH: Sodium Accumulation Study In Haemodialysis

End Stage Renal Disease on Dialysis Clinical Trial

— SASH  

Official title:

Sodium Accumulation Study In Haemodialysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05128188
• Other study ID #: UHDB/2021/020
• Status: Not yet recruiting
• Start date: January 15, 2022
• Est. completion date: June 15, 2022

Study information

• Verified date: November 2021
• Source: University Hospitals of Derby and Burton NHS Foundation Trust
• Contact: Rebecca Noble, Dr
• Phone: 01332340131
• Email: mszran[@]exmail.nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: June 15, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Haemodialysis
• Kidney Failure, Chronic

Intervention

Other:
• No intervention will be given in this study
No intervention will be given in this study

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Derby and Burton NHS Foundation Trust	Derby

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of Derby and Burton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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