Randomised Evaluation of Sodium Dialysate Levels on Vascular Events (RESOLVE)

• ClinicalTrials.gov Identifier: NCT02823821
• Recruitment Status: Recruiting
• First Posted: July 6, 2016
• Last Update Posted: October 10, 2022
• Sponsor: University of Sydney
• Collaborators: Australasian Kidney Trials Network; Australia & New Zealand Dialysis & Transplant Registry; The George Institute for Global Health, India; The George Institute for Global Health, China; Peking University People's Hospital; Institute for Clinical Evaluative Sciences; St. Michaels Hospital; University Hospital Wuerzburg, Medizinische Klinik EINS; Malaysian Society of Nephrology; Malaysian Renal Registry
• Information provided by (Responsible Party): University of Sydney

Tracking Information

• First Submitted Date: June 16, 2016
• First Posted Date: July 6, 2016
• Last Update Posted Date: October 10, 2022
• Actual Study Start Date: June 2016
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 20, 2017)

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.

Original Primary Outcome Measures (submitted: July 5, 2016)

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 myocardial infarction, hospitalised stroke, coronary artery or cerebrovascular revascularisation) and all-cause death. Study completion is endpoint driven, but is expected to be when the average follow up is around 5 years.

Current Secondary Outcome Measures (submitted: March 20, 2017)

• 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.
• 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.

Original Secondary Outcome Measures (submitted: July 5, 2016)

• 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 (as above), 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.
• 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, coronary artery revascularisations, cerebrovascular revascularisations, 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
• Official Title: Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
• Brief Summary: 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: End-Stage Kidney Disease

Intervention

• 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.
• 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.

Study Arms

• Active Comparator: 137mmol/l
  Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l
  Intervention: Other: Default dialysate sodium concentration of 137mmol/l
• Active Comparator: 140mmol/l
  Participating dialysis sites will be randomised to a default dialysate sodium concentration of 140mmol/l
  Intervention: Other: Default dialysate sodium concentration of 140mmol/l

• Publications *: See EJ, Polkinghorne KR. Volume management in haemodialysis patients. Curr Opin Nephrol Hypertens. 2020 Nov;29(6):663-670. doi: 10.1097/MNH.0000000000000642.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 28, 2022): 50000
• Original Estimated Enrollment (submitted: July 5, 2016): 51520
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Nuria Zamora Solano; nuria.zamora@sydney.edu.au

Contact: Erika Dempsey; erika.dempsey@sydney.edu.au

• Listed Location Countries: Australia, Canada, Germany, India
• Removed Location Countries: China

Administrative Information

• NCT Number: NCT02823821
• Other Study ID Numbers: GI-AU-RM-2016-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Sydney
• Original Responsible Party: The George Institute
• Current Study Sponsor: University of Sydney
• Original Study Sponsor: The George Institute

Collaborators

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

Investigators

• Study Director: Meg Jardine; The University of Sydney, NHMRC Clinical Trials Centre
• Study Chair: Carmel Hawley; The University of Queensland
• Study Chair: Vivekanand Jha; The George Institute India
• Study Chair: Zuo Li; Peking University People's Hospital
• Study Chair: Sunita Bavanandan; Kuala Lumpur General Hospital
• Study Chair: David Wheeler; University College, London
• Study Chair: Patrick Rossignol; INSERM Clinical Investigation Centre
• Study Chair: Mike Walsh; McMaster University
• Study Chair: Mark Marshall; University of Auckland, New Zealand
• Study Chair: Vlado Perkovic; University of New South Wales
• Study Chair: Christoph Wanner; University Hospital Wuerzburg
• Principal Investigator: Jule Pinter; University Hospital Wuerzburg

• PRS Account: University of Sydney
• Verification Date: October 2022