Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Time to first occurrence of an event in the primary composite outcome [Срок оценки: Through to study completion (estimated to occur after an average of 5 years follow up)]

Вторичные конечные точки (2)

• Time to first occurrence of an event in the secondary composite outcome [Срок оценки: 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. [Срок оценки: Through to study completion (estimated to occur after an average of 5 years follow up)]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Великобритания · 95 центров

Список центров уточняется — проверьте первичный протокол.

Индия · 63 центра

• Area Hospital, Kothapeta Road,Chirala, Andhra Pradesh — Chīrāla
• Government General Hospital — Guntur
• Medical Superintendent Government Hospital — Gūdūr
• Medical Superintendent District Hospital — Hindupur PPP
• Government Area Hospital, Kanigiri, Andhra Pradesh — Kanigiri
• Government Hospital — Kākināda
• Government General Hospital — Kurnool
• Government Hospital, Machilipatnam PPP, Andhra Pradesh — Machilipatnam
• … и ещё 55 центров

Малайзия · 39 центров

Список центров уточняется — проверьте первичный протокол.

Австралия · 31 центр

• Royal Adelaide Hospital — Adelaide
• Auburn Hospital — Auburn
• Flinders Medical Centre — Bedford Park
• Moorabbin Hospital — Bentleigh East
• Sunshine Coast University Private Hospital — Birtinya
• Princess Alexandra Hospital — Brisbane
• Redlands Hospital — Brisbane
• Bundaberg Hospital — Bundaberg
• … и ещё 23 центра

Канада · 20 центров

• Brantford General Hospital — Brantford
• Chatam-Kent Health Alliance — Chatham
• St Joseph's Healthcare — Hamilton
• Hanover District Hospital — Hanover
• Adam Linton Dialysis Unit - Victoria Hospital — London
• London Health Sciences Centre — London
• Westmount Kidney Care Centre — London
• Grey Bruce Health Services — Owen Sound
• … и ещё 12 центров

Германия · 16 центров

• Nephrologisches Zentrum Albstadt — Albstadt
• Praxis für Nierenkrankheiten Berlin Hellersdorf — Berlin
• Dialyse am Kortumpark Bochum — Bochum
• Dialysezentrum Darmstadt — Darmstadt
• Dialysezentrum Elsenfeld — Elsenfeld
• Nephrologisches Zentrum Hechingen — Hechingen
• Arbeitsgemeinschaft Heimdialyse Saar e.V. — Homburg
• Dialysezentrum Langen — Langen
• … и ещё 8 центров

Публикации

• Pinter J, Canaud B, Mayne KJ, Stuard S, Moissl U, Kooman J, Jager KJ, Chesnaye NC, Smyth B, Genser B. Associations of Abnormal Fluid Status, Plasma Sodium Disorders, and Low Dialysate Sodium with Mortality in Patients on Hemodialysis. Clin J Am Soc Nephrol. 2024 Nov 1;19(11):1444-1452. doi: 10.2215/CJN.0000000000000552. Epub 2024 Sep 10. PMID 39514693
• Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3. PMID 39498822
• See EJ, Polkinghorne KR. Volume management in haemodialysis patients. Curr Opin Nephrol Hypertens. 2020 Nov;29(6):663-670. doi: 10.1097/MNH.0000000000000642. PMID 32889978

Идентификаторы

NCT: NCT02823821 · GI-AU-RM-2016-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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