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NCT Number: NCT02823821

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

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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Key information

Conditions

End-stage Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Adelaide Hospital, Adelaide, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The site inclusion criteria are:

  • 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].

The exclusion criteria are:

  • Not able to comply with data collection methods

Treatment and study plan

Default dialysate sodium concentration of 137mmol/l

Other

Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.

Default dialysate sodium concentration of 140mmol/l

Other

Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.

Primary outcomes

  1. Time to first occurrence of an event in the primary composite outcome

    Time frame: Through to study completion (estimated to occur after an average of 5 years follow up)

    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.

Secondary outcomes

  1. Time to first occurrence of an event in the secondary composite outcome

    Time frame: Through to study completion (estimated to occur after an average of 5 years follow up)

    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.

  2. Time to first occurrence of each of the individual components of the composite outcomes.

    Time frame: Through to study completion (estimated to occur after an average of 5 years follow up)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erika Dempsey

CONTACT

[email protected]

Grace Balicki

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Collaborators

  • Australasian Kidney Trials Network
  • Australia & New Zealand Dialysis & Transplant Registry
  • Institute for Clinical Evaluative Sciences
  • Malaysian Renal Registry
  • Malaysian Society of Nephrology
  • Peking University People's Hospital
  • St. Michaels Hospital
  • The George Institute
  • The George Institute for Global Health, China
  • University College, London
  • Wuerzburg University Hospital

Registry information

Acronym: RESOLVE

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2016
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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