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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02823821
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : October 10, 2022
Sponsor:
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  ICMJE June 16, 2016
First Posted Date  ICMJE July 6, 2016
Last Update Posted Date October 10, 2022
Actual Study Start Date  ICMJE June 2016
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE End-Stage Kidney Disease
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 28, 2022)
50000
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2016)
51520
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nuria Zamora Solano nuria.zamora@sydney.edu.au
Contact: Erika Dempsey erika.dempsey@sydney.edu.au
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   India
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT02823821
Other Study ID Numbers  ICMJE GI-AU-RM-2016-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Sydney
Original Responsible Party The George Institute
Current Study Sponsor  ICMJE University of Sydney
Original Study Sponsor  ICMJE The George Institute
Collaborators  ICMJE
  • 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  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP