Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

  • STATUS
    Recruiting
  • End date
    Dec 23, 2023
  • participants needed
    51520
  • sponsor
    The George Institute
Updated on 23 November 2020
Investigator
Erika Dempsey
Primary Contact
Concord Repatriation and General Hospital (3.5 mi away) Contact
+161 other location
dialysis
maintenance haemodialysis

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.

Description

RESOLVE is a pragmatic, cluster-randomised, open-label trial 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 2-5 years with average study duration expected to be approximately 5 years. The actual length of the study will be end-point determined.

The study will involve a staged roll-out. The initial Development Phase will ascertain the feasibility of implementing the study protocol. The vanguard phase will continue to implement the protocol and allow testing of study assumptions. The main phase will conclude the study.

Details
Treatment Default dialysate sodium concentration of 137mmol/l, Default dialysate sodium concentration of 140mmol/l
Clinical Study IdentifierNCT02823821
SponsorThe George Institute
Last Modified on23 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Chronic renal failure?
Do you have any of these conditions: Stage 5 Chronic Kidney Disease or Chronic Kidney Disease Stage 5 or chronic renal disease or end stage renal failure or end-stage renal disease or end...?
Do you have any of these conditions: chronic renal disease or end stage renal disease or end stage kidney disease or Stage 5 Chronic Kidney Disease or end-stage renal failure or end stage...?
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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