RecruitingPhase 3ACTRN12611000975998

The effect of lower salt exposure on the cardiac structure and function of patients on home haemodialysis

A randomised, controlled trial of low sodium dialysate versus conventional sodium dialysate to reduce left ventricular mass index in patients receiving home 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

Cardiovascular outcomes in dialysis patients

Summary

Home haemodialysis is a common and relatively inexpensive form of dialysis in New Zealand that generally provides good quality of life. However, survival is still poor compared to the general population and 67% of patients die from cardiovascular disease. The SOLID Trial evaluates a cost-free intervention that would potentially improve these patients’ cardiovascular outcomes. The intervention involves reducing salt administration during routine dialysis. Earlier research in South Auckland showed that this simple measure reduces blood pressure. The SOLID Trial tests whether this measure also improves cardiac structure and function, since this would in turn reduce the risk of sudden cardiac death. If the intervention works, it would become the standard practice both locally and globally, and improve survival for all dialysis patients but especially those undergoing home HD. Remarkably, the intervention may be one of the few in medicine to provide health benefits at no added cost.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study (called the SOLID Trial) is testing whether reducing the amount of salt used during home dialysis can improve heart health in people with kidney failure. Dialysis patients have a very high risk of dying from heart disease, and researchers believe that simply lowering the salt content of dialysis fluid could help. This is a cost-free change that could save lives. You may be eligible if: - You are 18 years or older - You are on home haemodialysis or self-care facility haemodialysis for kidney failure - Your blood sodium level is normal or above normal - Your kidney specialist agrees you are suitable for both low and standard salt dialysis You may NOT be eligible if: - You receive dialysis more than 3.5 times per week - You are expected to live less than 12 months - You are scheduled for a kidney transplant within the next 12 months - You have a known serious heart muscle disease (such as amyloid or hypertrophic cardiomyopathy) - You have 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.

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Interventions

Low dialysate [Na+] at 135mM up to (and including) 3.5 times per week at every haemodialysis treatment for 12 months

Locations(1)

New Zealand

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ACTRN12611000975998