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Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

PHASE4RECRUITING

This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.

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Study details:

RESOLVE is a pragmatic, cluster-randomised, open-label study designed to evaluate in real-world conditions the comparative effectiveness of two default dialysate sodium concentrations. Dialysis sites will be randomised in a 1:1 ratio to a default dialysate sodium concentration of 137mmol/l or 140mmol/l. 'Default' is defined as the use of the allocated dialysate sodium for ≥ 90% of delivered dialysis sessions in the unit.

All other care will be according to standard local practices as determined by the site. Outcomes will be assessed on individual patients dialysing at those sites. Sites will be asked to consent to participation while waiver or opt-out consent will be sought for individual patients.

It is anticipated that site accrual will occur over 5-7 years with average study duration expected to be approximately 2-5 years. The actual length of the study will be end-point determined.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Predominantly dialyses adults (≥18 years old) receiving maintenance haemodialysis

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%

Has a minimum of 10 dialysis recipients at time of randomisation

Utilises a default dialysate sodium concentration at the time of recruitment (a substantial majority of dialysis sessions are conducted with the default dialysate sodium concentration)

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)

Willing to accept randomisation to either intervention (as determined by nominated Director of Unit)

Is not a home dialysis training or support unit. [Sites that include both in-center/satellite dialysis patients and home patients may participate but the study procedures and assessments will only be conducted in the incenter/satellite component of the site].

Exclusion criteria

Not able to comply with data collection methods

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2016-06-01

Primary completion: 2024-12-01

Study completion finish: 2024-12-01

Study type

HEALTH_SERVICES_RESEARCH

Phase

PHASE4

Trial ID

NCT02823821

Intervention or treatment

OTHER: Default dialysate sodium concentration of 137mmol/l

OTHER: Default dialysate sodium concentration of 140mmol/l

Conditions

• End-Stage Kidney Disease

Image related to End-Stage Kidney Disease

Condition: End-Stage Kidney Disease
OTHER: Default dialysate sodium concentration of 137mmol/l and other drugs
Adelaide, Not Specified, Australia and more
Sponsor: University of Sydney

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Find a site

Closest Location:

Royal Adelaide Hospital

Research sites nearby

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, Not Specified, Australia
Royal Prince Alfred Hospital
Camperdown, Not Specified, Australia
Westmead Hospital
Sydney, Not Specified, Australia
Auburn Hospital
Auburn, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: 137mmol/l Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l	OTHER: Default dialysate sodium concentration of 137mmol/l Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
ACTIVE_COMPARATOR: 140mmol/l Participating dialysis sites will be randomised to a default dialysate sodium concentration of 140mmol/l	OTHER: Default dialysate sodium concentration of 140mmol/l Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Time to first occurrence of an event in the primary composite outcome	Primary outcome is a composite of major cardiovascular events (hospitalised acute myocardial infarction, hospitalised stroke) and all-cause death. Study completion is endpoint driven, but is expected to be when the average follow up is around 5 years.	Through to study completion (estimated to occur after an average of 5 years follow up)

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Time to first occurrence of an event in the secondary composite outcome	Secondary outcome comprises major cardiovascular events (hospitalized acute myocardial infarction, hospitalized stroke), all-cause death and hospitalized heart failure. Study completion is endpoint driven, but is expected to be when the average follow up is around 5 years.	Through to study completion (estimated to occur after an average of 5 years follow up)
Time to first occurrence of each of the individual components of the composite outcomes.	These components are hospitalised myocardial infarctions, hospitalised strokes, hospitalised heart failures and all-cause deaths. Study completion is endpoint driven, but is expected to be when the average follow up is around 5 years.	Through to study completion (estimated to occur after an average of 5 years follow up)

Frequently Asked Questions

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References

Clinical Trials Gov: Randomised Evaluation of Sodium Dialysate Levels on Vascular Events