Randomised evaluation of sodium dialysate levels on vascular events

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 100

Inclusion Criteria

The principal SITE inclusion criteria are dialysis units that:
1. Predominantly dialyse adults (=18 years old) receiving maintenance haemodialysis
2. Rates of withdrawal within the first two years of commencing dialysis for social reasons have been less than 15% for the 2 years prior to recruitment and are not expected to increase above 15%
3. Has a minimum of 10 dialysis recipients at the time of randomisation
4. Utilises a default dialysate sodium concentration at the time of recruitment (i.e. a substantial majority of dialysis sessions are conducted with the default dialysate sodium concentration)
5. Is a self-contained unit (i.e. unit patients do not regularly rotate through another unit. Brief trips by patients to a parent or other unit do not exclude a site). Note: If two or more sites have regularly rotating patients, these sites may be randomised together as a cluster.
6. Willing to accept randomisation to either intervention (as determined by the nominated Director of Unit)
7. Is not a home dialysis training or support unit (sites that include both in-centre or satellite dialysis patients and home patients may participate but the study procedures and assessments will only be conducted in the in-centre/satellite component of the site)

Exclusion Criteria

The principal SITE exclusion criteria are dialysis units that are:
1. Not able to comply with data collection methods

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The composite of hospitalised myocardial infarction, hospitalised stroke, and all-cause death, all measured using NHS Digital data at annual timepoints

Secondary Outcome Measures

Name	Time	Method
1. Hospitalised heart failure measured using NHS Digital data at annual timepoints<br>2. The time between these events (hospitalised acute myocardial infarction, hospitalised stroke, hospitalised heart failure and death) measured using NHS Digital data at annual timepoints<br>3. Health economics will be performed to calculate potential costs and health-related outcomes in patients undergoing dialysis with a sodium concentration of 137 mmol/l vs sodium concentration of 140 mmol/l over the duration of the study