RecruitingPhase 3ACTRN12614000070639

The effect of lower salt exposure at haemodialysis on cardiac micro-injury, in home and self-care haemodialysis patients.

A randomised controlled trial of low versus normal dialysate sodium, to assess the effect on myocardial micro-injury in patients on home and self-care haemodialysis


Sponsor

The Centre for Clinical Research and effective practice (CCRep), registered with the New Zealand Charities Commission (ref# CC21537)

Enrollment

118 participants

Start Date

Mar 26, 2012

Study Type

Interventional

Conditions

Summary

The SOLID Trial (ACTRN12611000975998) is currently underway. Its hypothesis is that reduced sodium exposure through the use of lower dialysate sodium concentration will reduce cardiovascular morbidity in haemodialysis patients, by reducing inter-dialytic hypertension and LV mass. The Mac-Solid Extension trial will evaluate whether any benefit of lower dialysate sodium in reducing inter-dialytic hypertension and LV mass might be offset by increased rates of intra-dialytic hypotension and myocardial micro-injury.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether using a lower amount of sodium (salt) in the fluid used during dialysis can reduce heart problems in people who do home or self-care haemodialysis. Researchers want to check whether any benefit is offset by low blood pressure episodes during dialysis and small amounts of heart muscle injury. You may be eligible if: - You are 18 years or older - You are on home or self-care haemodialysis for kidney failure - Your blood sodium level is 135 mmol/L or higher before dialysis - Your doctor agrees that both low and standard sodium dialysate (dialysis fluid) are suitable for you - You are willing to participate and have signed the consent form You may NOT be eligible if: - You have dialysis more than 3.5 times per week - You receive haemodiafiltration (a different type of dialysis) - Your life expectancy is less than 12 months - You are scheduled for a live-donor kidney transplant within 12 months - You have conditions that make study procedures unsafe (such as frequent low blood pressure during dialysis) - You are already enrolled in another trial testing blood pressure or dialysis changes - You have infiltrative or hereditary heart muscle disease, or moderate to severe aortic valve disease Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Low dialysate [Na+] at 135mM up to (and including) 7 times per fortnight (average 3.5 times per week) at every haemodialysis treatment for 12 months. Dialysate Na+ will be set in service mode and loc

Low dialysate [Na+] at 135mM up to (and including) 7 times per fortnight (average 3.5 times per week) at every haemodialysis treatment for 12 months. Dialysate Na+ will be set in service mode and locked to 135mM on patient's machine, so as machine defaults to 135mM every time it is turned on for the 12 month study period.


Locations(1)

New Zealand

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12614000070639