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

Primary Purpose

End-Stage Kidney Disease

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Default dialysate sodium concentration of 137mmol/l
Default dialysate sodium concentration of 140mmol/l
Sponsored by
University of Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End-Stage Kidney Disease focused on measuring End-Stage Kidney Disease, Hemodialysis, Dialysate, Sodium, Cluster-randomisation, Dialysis, RESOLVE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Adelaide HospitalRecruiting
  • Auburn HospitalRecruiting
  • Flinders Medical CentreRecruiting
  • Moorabbin HospitalRecruiting
  • Sunshine Coast University Private HospitalRecruiting
  • Princess Alexandra HospitalRecruiting
  • Redlands HospitalRecruiting
  • Bundaberg HospitalRecruiting
  • Caloundra HospitalRecruiting
  • The Canberra HospitalRecruiting
  • Peninsula HealthRecruiting
  • Gympie HospitalRecruiting
  • Ipswich HospitalRecruiting
  • Mackay Base HospitalRecruiting
  • Logan HospitalRecruiting
  • Monash Health Community DandenongRecruiting
  • Casey HospitalRecruiting
  • Cranbourne Integrated Care CentreRecruiting
  • Nambour General HospitalRecruiting
  • Hampstead Dialysis CentreRecruiting
  • Hervey Bay HospitalRecruiting
  • Royal North Shore HospitalRecruiting
  • Sunshine Coast University HospitalRecruiting
  • Sydney Adventist HospitalRecruiting
  • Concord Repatriation and General HospitalRecruiting
  • Blacktown Regional Dialysis CentreRecruiting
  • Mt Druitt Community Dialysis CentreRecruiting
  • Nepean HospitalRecruiting
  • Westmead HospitalRecruiting
  • The Queen Elizabeth HospitalRecruiting
  • Brantford General HospitalRecruiting
  • Chatam-Kent Health AllianceRecruiting
  • St Joseph's HealthcareRecruiting
  • Hanover District HospitalRecruiting
  • Adam Linton Dialysis Unit - Victoria HospitalRecruiting
  • London Health Sciences CentreRecruiting
  • Westmount Kidney Care CentreRecruiting
  • Grey Bruce Health ServicesRecruiting
  • Bluewater HospitalRecruiting
  • Huron Perth Hospital PartnershipRecruiting
  • Tillsonburg District Memorial HospitalRecruiting
  • Woodstock General HospitalRecruiting
  • Stoney CreekRecruiting
  • BellevilleRecruiting
  • BrockvilleRecruiting
  • Kingston GeneralRecruiting
  • NapaneeRecruiting
  • Perth and Smith FallsRecruiting
  • PictonRecruiting
  • St. Michael's HospitalRecruiting
  • Praxis für Nierenkrankheiten Berlin HellersdorfRecruiting
  • Dialyse am Kortumpark BochumRecruiting
  • Dialysezentrum ElsenfeldRecruiting
  • Arbeitsgemeinschaft Heimdialyse Saar e.V.Recruiting
  • KfH Nierenzentrum LichtenfelsRecruiting
  • Universitätsmedizin Mainz, Dialysestation 605-5ERecruiting
  • KfH Nierenzentrum München SchwabingRecruiting
  • Dialysezentrum SchweinfurtRecruiting
  • Nephrologisches Zentrum Villingen-Schwenningen -TuttlingenRecruiting
  • Area Hospital, Kothapeta Road,Chirala, Andhra PradeshRecruiting
  • Medical Superintendent Government HospitalRecruiting
  • Government General HospitalRecruiting
  • Medical Superintendent District HospitalRecruiting
  • Government Area Hospital, Kanigiri, Andhra PradeshRecruiting
  • Government General HospitalRecruiting
  • Government HospitalRecruiting
  • Government Hospital, Machilipatnam PPP, Andhra PradeshRecruiting
  • Government Area HospitalRecruiting
  • Government HospitalRecruiting
  • Area HospitalRecruiting
  • Government Area HospitalRecruiting
  • CHC Government HospitalRecruiting
  • Government Area HospitalRecruiting
  • Government HospitalRecruiting
  • Government HospitalRecruiting
  • CHC Hospital, Sompeta, Andhra PradeshRecruiting
  • Greater Kailash HospitalRecruiting
  • Manasa Kidney FoundationRecruiting
  • Government General Hospital, Vijayavada PPP, Andhra PradeshRecruiting
  • King George Government HospitalRecruiting
  • Rajiv Gandhi Institute of Medical Sciences, Srikakulam PPP, AndhraRecruiting
  • Ford Hospital, Khemnichak, PatnaRecruiting
  • Janak Dulari Hospital, Hanuman NagarRecruiting
  • Aysha HospitalRecruiting
  • Retteri Sri Kumaran Health CentreRecruiting
  • Leelawati HospitalRecruiting
  • Greater Kailash HospitalRecruiting
  • ESI HospitalRecruiting
  • K.M Memorial Hospital and Research CentreRecruiting
  • Asarfi HospitalRecruiting
  • Bhagwan Mahavir Medical Superspeciality HospitalRecruiting
  • Guru Nanak Hospital and Research CentreRecruiting
  • Koshys Hospital, Ramamurthy NagarRecruiting
  • Nephroplus BasaveshwaranagarRecruiting
  • Fortis Suchirayu HospitalRecruiting
  • Main Hospital, SCCLRecruiting
  • Vishesh Hospital Pvt. Ltd, Geeta Bhawan ChourahaRecruiting
  • Hitwardhak Mandal HospitalRecruiting
  • Lokmanya HospitalRecruiting
  • Chirayu HospitalRecruiting
  • Nephroplus Borivali StandaloneRecruiting
  • Bharat BaugRecruiting
  • Jyothi HospitalRecruiting
  • Kar Clinic & Hospital Pvt. Ltd.Recruiting
  • Neelachal Hospital, Kharvel NagarRecruiting
  • Satguru Partap Singh Apollo HospitalsRecruiting
  • KG HospitalRecruiting
  • Sudha Hospital, VadalurRecruiting
  • Deepam Hospitals, PallavaramRecruiting
  • Neyveli Lignite Corporation HospitalRecruiting
  • Citizens Specialty HospitalRecruiting
  • ESI Multi-Specialty HospitalRecruiting
  • Vintage Plaza Nephroplus, Road no. 10, Banjara HillsRecruiting
  • Government HospitalRecruiting
  • Suraksha Multispecialty HospitalRecruiting
  • Nephroplus Standalone Dialysis Center, Easy MarredpallyRecruiting
  • Madhuraj HospitalRecruiting
  • Ajanta HospitalRecruiting
  • Surbhi Hospital Pvt. Ltd, Sector 35Recruiting
  • Health Point Hospital, Prannth Pandit StreetRecruiting
  • Minimal Access Surgery Clinic Pvt LtdRecruiting
  • Baroma Sirona HospitalRecruiting
  • Hospital AmpangRecruiting
  • Hospital Sultanah Nora IsmailRecruiting
  • Hospital BeaufortRecruiting
  • Hospital Pulau PinangRecruiting
  • Pusat Dialisis NKF- Yayasan Dialisis Pendidikan Akhlak PerakRecruiting
  • Hospital Sultan IsmailRecruiting
  • Hospital Sultanah AminahRecruiting
  • Hospital KajangRecruiting
  • Hospital SerdangRecruiting
  • Hospital Tuanku Fauziah
  • Pusat Rawatan Dialisis Tuanku Syed Putra - NKFRecruiting
  • Hospital Tengku Ampuan RahimahRecruiting
  • Pusat Daillisis NKF - Kelab ApexRecruiting
  • Hospital Raja Perempuan Zainab IIRecruiting
  • Hospital LikasRecruiting
  • Hospital Queen Elizabeth IIRecruiting
  • Hospital Kuala KangsarRecruiting
  • Hospital Kuala LipisRecruiting
  • Hospital Kuala LumpurRecruiting
  • Pusat Dialisis NKF-Fungates SuperflowRecruiting
  • Pusat Dialisis NKF-NanyangRecruiting
  • Universiti Kebangsaan Malaysia Medical CentreRecruiting
  • University of Malaya Medical CentreRecruiting
  • Hospital Tengku Ampuan AfzanRecruiting
  • Hospital KudatRecruiting
  • Hospital KulimRecruiting
  • Hospital LabuanRecruiting
  • Hospital Sultanah BahiyahRecruiting
  • Haemodialysis Unit Klinik Kesihatan LenggongRecruiting
  • Pusat Hemodialisis Komuniti ChengRecruiting
  • Hospital Pakar Sultanah FatimahRecruiting
  • Hospital Seberang JayaRecruiting
  • Pusat Dialisis NKF - ChempakaRecruiting
  • Hospital Shah AlamRecruiting
  • Universiti Teknologi MaraRecruiting
  • Hospital Sultan Abdul HalimRecruiting
  • Hospital Sungai SiputRecruiting
  • Hospital TambunanRecruiting
  • Hospital Sultan Haji Ahmad ShahRecruiting
  • Barnet Satellite UnitRecruiting
  • Edgware Satellite UnitRecruiting
  • Mary Rankin Satellite UnitRecruiting
  • Royal London HospitalRecruiting
  • Newham HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

137mmol/l

140mmol/l

Arm Description

Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l

Participating dialysis sites will be randomised to a default dialysate sodium concentration of 140mmol/l

Outcomes

Primary Outcome Measures

Time to first occurrence of an event in the primary composite outcome
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 Outcome Measures

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

Full Information

First Posted
June 16, 2016
Last Updated
July 7, 2023
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, Comprehensive Clinical Trials Unit, University College London
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1. Study Identification

Unique Protocol Identification Number
NCT02823821
Brief Title
Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Acronym
RESOLVE
Official Title
Randomised Evaluation of Sodium Dialysate Levels on Vascular Events
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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, Comprehensive Clinical Trials Unit, University College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Kidney Disease
Keywords
End-Stage Kidney Disease, Hemodialysis, Dialysate, Sodium, Cluster-randomisation, Dialysis, RESOLVE

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
137mmol/l
Arm Type
Active Comparator
Arm Description
Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l
Arm Title
140mmol/l
Arm Type
Active Comparator
Arm Description
Participating dialysis sites will be randomised to a default dialysate sodium concentration of 140mmol/l
Intervention Type
Other
Intervention Name(s)
Default dialysate sodium concentration of 137mmol/l
Intervention Description
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
Intervention Type
Other
Intervention Name(s)
Default dialysate sodium concentration of 140mmol/l
Intervention Description
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
Primary Outcome Measure Information:
Title
Time to first occurrence of an event in the primary composite outcome
Description
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.
Time Frame
Through to study completion (estimated to occur after an average of 5 years follow up)
Secondary Outcome Measure Information:
Title
Time to first occurrence of an event in the secondary composite outcome
Description
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 Frame
Through to study completion (estimated to occur after an average of 5 years follow up)
Title
Time to first occurrence of each of the individual components of the composite outcomes.
Description
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.
Time Frame
Through to study completion (estimated to occur after an average of 5 years follow up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuria Zamora Solano
Email
nuria.zamora@sydney.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Dempsey
Email
erika.dempsey@sydney.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meg Jardine
Organizational Affiliation
The University of Sydney, NHMRC Clinical Trials Centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carmel Hawley
Organizational Affiliation
The University of Queensland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vivekanand Jha
Organizational Affiliation
The George Institute India
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zuo Li
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sunita Bavanandan
Organizational Affiliation
Kuala Lumpur General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Wheeler
Organizational Affiliation
Comprehensive Clinical Trials Unit, University College London
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patrick Rossignol
Organizational Affiliation
INSERM Clinical Investigation Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mike Walsh
Organizational Affiliation
McMaster University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mark Marshall
Organizational Affiliation
University of Auckland, New Zealand
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vlado Perkovic
Organizational Affiliation
University of New South Wales
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christoph Wanner
Organizational Affiliation
University Hospital Wuerzburg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jule Pinter
Organizational Affiliation
University Hospital Wuerzburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Individual Site Status
Recruiting
Facility Name
Auburn Hospital
City
Auburn
ZIP/Postal Code
2144
Country
Australia
Individual Site Status
Recruiting
Facility Name
Flinders Medical Centre
City
Bedford Park
Country
Australia
Individual Site Status
Recruiting
Facility Name
Moorabbin Hospital
City
Bentleigh East
ZIP/Postal Code
3165
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sunshine Coast University Private Hospital
City
Birtinya
Country
Australia
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
Brisbane
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Redlands Hospital
City
Brisbane
ZIP/Postal Code
4163
Country
Australia
Individual Site Status
Recruiting
Facility Name
Bundaberg Hospital
City
Bundaberg
Country
Australia
Individual Site Status
Recruiting
Facility Name
Caloundra Hospital
City
Caloundra
ZIP/Postal Code
4551
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Canberra Hospital
City
Canberra
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peninsula Health
City
Frankston
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Recruiting
Facility Name
Gympie Hospital
City
Gympie
ZIP/Postal Code
4570
Country
Australia
Individual Site Status
Recruiting
Facility Name
Ipswich Hospital
City
Ipswich
ZIP/Postal Code
4305
Country
Australia
Individual Site Status
Recruiting
Facility Name
Mackay Base Hospital
City
Mackay
Country
Australia
Individual Site Status
Recruiting
Facility Name
Logan Hospital
City
Meadowbrook
ZIP/Postal Code
4131
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Health Community Dandenong
City
Melbourne
ZIP/Postal Code
3175
Country
Australia
Individual Site Status
Recruiting
Facility Name
Casey Hospital
City
Melbourne
ZIP/Postal Code
3806
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cranbourne Integrated Care Centre
City
Melbourne
ZIP/Postal Code
3977
Country
Australia
Individual Site Status
Recruiting
Facility Name
Nambour General Hospital
City
Nambour
ZIP/Postal Code
4560
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hampstead Dialysis Centre
City
Northfield
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hervey Bay Hospital
City
Pialba
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal North Shore Hospital
City
St Leonards
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sunshine Coast University Hospital
City
Sunshine Coast
ZIP/Postal Code
4575
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sydney Adventist Hospital
City
Sydney
ZIP/Postal Code
2076
Country
Australia
Individual Site Status
Recruiting
Facility Name
Concord Repatriation and General Hospital
City
Sydney
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Name
Blacktown Regional Dialysis Centre
City
Sydney
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Recruiting
Facility Name
Mt Druitt Community Dialysis Centre
City
Sydney
ZIP/Postal Code
2770
Country
Australia
Individual Site Status
Recruiting
Facility Name
Nepean Hospital
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Name
Westmead Hospital
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
Country
Australia
Individual Site Status
Recruiting
Facility Name
Brantford General Hospital
City
Brantford
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Chatam-Kent Health Alliance
City
Chatham
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
St Joseph's Healthcare
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hanover District Hospital
City
Hanover
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Adam Linton Dialysis Unit - Victoria Hospital
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Westmount Kidney Care Centre
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Grey Bruce Health Services
City
Owen Sound
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Bluewater Hospital
City
Sarnia
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Huron Perth Hospital Partnership
City
Stratford
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Tillsonburg District Memorial Hospital
City
Tillsonburg
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Woodstock General Hospital
City
Woodstock
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Stoney Creek
City
Hamilton
Country
Canada
Individual Site Status
Recruiting
Facility Name
Belleville
City
Kingston
Country
Canada
Individual Site Status
Recruiting
Facility Name
Brockville
City
Kingston
Country
Canada
Individual Site Status
Recruiting
Facility Name
Kingston General
City
Kingston
Country
Canada
Individual Site Status
Recruiting
Facility Name
Napanee
City
Kingston
Country
Canada
Individual Site Status
Recruiting
Facility Name
Perth and Smith Falls
City
Kingston
Country
Canada
Individual Site Status
Recruiting
Facility Name
Picton
City
Kingston
Country
Canada
Individual Site Status
Recruiting
Facility Name
St. Michael's Hospital
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Name
Praxis für Nierenkrankheiten Berlin Hellersdorf
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dialyse am Kortumpark Bochum
City
Bochum
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dialysezentrum Elsenfeld
City
Elsenfeld
Country
Germany
Individual Site Status
Recruiting
Facility Name
Arbeitsgemeinschaft Heimdialyse Saar e.V.
City
Homburg
Country
Germany
Individual Site Status
Recruiting
Facility Name
KfH Nierenzentrum Lichtenfels
City
Lichtenfels
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin Mainz, Dialysestation 605-5E
City
Mainz
Country
Germany
Individual Site Status
Recruiting
Facility Name
KfH Nierenzentrum München Schwabing
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dialysezentrum Schweinfurt
City
Schweinfurt
Country
Germany
Individual Site Status
Recruiting
Facility Name
Nephrologisches Zentrum Villingen-Schwenningen -Tuttlingen
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Individual Site Status
Recruiting
Facility Name
Area Hospital, Kothapeta Road,Chirala, Andhra Pradesh
City
Chirala
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Medical Superintendent Government Hospital
City
Gudur
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Government General Hospital
City
Guntur
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Medical Superintendent District Hospital
City
Hindupur PPP
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Government Area Hospital, Kanigiri, Andhra Pradesh
City
Kanigiri
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Government General Hospital
City
Kurnool
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Government Hospital
City
Kākināda
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Government Hospital, Machilipatnam PPP, Andhra Pradesh
City
Machilipatnam
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Government Area Hospital
City
Markapur
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Government Hospital
City
Nandyal
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Area Hospital
City
Narsipatnam
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Government Area Hospital
City
Palakonda, Srikakulam District
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
CHC Government Hospital
City
Palasa
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Government Area Hospital
City
Parvathipuram
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Government Hospital
City
Proddatur
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Government Hospital
City
Rajahmundry
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
CHC Hospital, Sompeta, Andhra Pradesh
City
Sompeta
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Greater Kailash Hospital
City
Tadepalligudem
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Manasa Kidney Foundation
City
Tirupati
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Government General Hospital, Vijayavada PPP, Andhra Pradesh
City
Vijayavada
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
King George Government Hospital
City
Visakhapatnam
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Rajiv Gandhi Institute of Medical Sciences, Srikakulam PPP, Andhra
City
Srikakulam
State/Province
Andhra
Country
India
Individual Site Status
Recruiting
Facility Name
Ford Hospital, Khemnichak, Patna
City
Patna
State/Province
Bihar
Country
India
Individual Site Status
Recruiting
Facility Name
Janak Dulari Hospital, Hanuman Nagar
City
Patna
State/Province
Bihar
Country
India
Individual Site Status
Recruiting
Facility Name
Aysha Hospital
City
Kilpauk
State/Province
Chennai
Country
India
Individual Site Status
Recruiting
Facility Name
Retteri Sri Kumaran Health Centre
City
Kolathur
State/Province
Chennai
Country
India
Individual Site Status
Recruiting
Facility Name
Leelawati Hospital
City
Ambāla
State/Province
Haryana
Country
India
Individual Site Status
Recruiting
Facility Name
Greater Kailash Hospital
City
Old Palasia
State/Province
Indore
Country
India
Individual Site Status
Recruiting
Facility Name
ESI Hospital
City
Adityapur
State/Province
Jharkand
Country
India
Individual Site Status
Recruiting
Facility Name
K.M Memorial Hospital and Research Centre
City
Bokaro
State/Province
Jharkhand
Country
India
Individual Site Status
Recruiting
Facility Name
Asarfi Hospital
City
Dhanbad
State/Province
Jharkhand
Country
India
Individual Site Status
Recruiting
Facility Name
Bhagwan Mahavir Medical Superspeciality Hospital
City
Ranchi
State/Province
Jharkhand
Country
India
Individual Site Status
Recruiting
Facility Name
Guru Nanak Hospital and Research Centre
City
Ranchi
State/Province
Jharkhand
Country
India
Individual Site Status
Recruiting
Facility Name
Koshys Hospital, Ramamurthy Nagar
City
Bengaluru
State/Province
Karnataka
Country
India
Individual Site Status
Recruiting
Facility Name
Nephroplus Basaveshwaranagar
City
Bengaluru
State/Province
Karnataka
Country
India
Individual Site Status
Recruiting
Facility Name
Fortis Suchirayu Hospital
City
Hubli
State/Province
Karnataka
Country
India
Individual Site Status
Recruiting
Facility Name
Main Hospital, SCCL
City
Kothagudem
State/Province
Khammam
Country
India
Individual Site Status
Recruiting
Facility Name
Vishesh Hospital Pvt. Ltd, Geeta Bhawan Chouraha
City
Indore
State/Province
Madhya Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Hitwardhak Mandal Hospital
City
Mumbai
State/Province
Maharashtra
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamal D Shah
First Name & Middle Initial & Last Name & Degree
Abhinav Bassi
Facility Name
Lokmanya Hospital
City
Pune
State/Province
Maharashtra
Country
India
Individual Site Status
Recruiting
Facility Name
Chirayu Hospital
City
Thāne
State/Province
Maharashtra
Country
India
Individual Site Status
Recruiting
Facility Name
Nephroplus Borivali Standalone
City
Borivali West
State/Province
Mumbai
ZIP/Postal Code
400092
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamal D Shah
First Name & Middle Initial & Last Name & Degree
Abhinav Bassi
Facility Name
Bharat Baug
City
Borivali West
State/Province
Mumbai
Country
India
Individual Site Status
Recruiting
Facility Name
Jyothi Hospital
City
Balasore
State/Province
Odisha
Country
India
Individual Site Status
Recruiting
Facility Name
Kar Clinic & Hospital Pvt. Ltd.
City
Bhubaneswar
State/Province
Odisha
Country
India
Individual Site Status
Recruiting
Facility Name
Neelachal Hospital, Kharvel Nagar
City
Bhubaneswar
State/Province
Odisha
Country
India
Individual Site Status
Recruiting
Facility Name
Satguru Partap Singh Apollo Hospitals
City
Ludhiāna
State/Province
Punjab
Country
India
Individual Site Status
Recruiting
Facility Name
KG Hospital
City
Coimbatore
State/Province
Tamil Nadu
Country
India
Individual Site Status
Recruiting
Facility Name
Sudha Hospital, Vadalur
City
Neyveli
State/Province
Tamil Nadu
Country
India
Individual Site Status
Recruiting
Facility Name
Deepam Hospitals, Pallavaram
City
Chennai
State/Province
Tamilnadu
Country
India
Individual Site Status
Recruiting
Facility Name
Neyveli Lignite Corporation Hospital
City
Neyveli
State/Province
Tamilnadu
Country
India
Individual Site Status
Recruiting
Facility Name
Citizens Specialty Hospital
City
Hyderabad
State/Province
Telangana
Country
India
Individual Site Status
Recruiting
Facility Name
ESI Multi-Specialty Hospital
City
Hyderabad
State/Province
Telangana
Country
India
Individual Site Status
Recruiting
Facility Name
Vintage Plaza Nephroplus, Road no. 10, Banjara Hills
City
Hyderabad
State/Province
Telangana
Country
India
Individual Site Status
Recruiting
Facility Name
Government Hospital
City
Khammam
State/Province
Telangana
Country
India
Individual Site Status
Recruiting
Facility Name
Suraksha Multispecialty Hospital
City
Nalgonda
State/Province
Telangana
Country
India
Individual Site Status
Recruiting
Facility Name
Nephroplus Standalone Dialysis Center, Easy Marredpally
City
Secunderabad
State/Province
Telangana
Country
India
Individual Site Status
Recruiting
Facility Name
Madhuraj Hospital
City
Kanpur
State/Province
Uttar Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Ajanta Hospital
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Individual Site Status
Recruiting
Facility Name
Surbhi Hospital Pvt. Ltd, Sector 35
City
Noida
State/Province
Uttar Pradish
Country
India
Individual Site Status
Recruiting
Facility Name
Health Point Hospital, Prannth Pandit Street
City
Kolkata
State/Province
West Bengal
Country
India
Individual Site Status
Recruiting
Facility Name
Minimal Access Surgery Clinic Pvt Ltd
City
Tamluk
State/Province
West Bengal
Country
India
Individual Site Status
Recruiting
Facility Name
Baroma Sirona Hospital
City
Uttar Mechgram
State/Province
West Bengal
Country
India
Individual Site Status
Recruiting
Facility Name
Hospital Ampang
City
Ampang
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Sultanah Nora Ismail
City
Batu Pahat
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Beaufort
City
Beaufort
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Pulau Pinang
City
George Town
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Pusat Dialisis NKF- Yayasan Dialisis Pendidikan Akhlak Perak
City
Ipoh
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Sultan Ismail
City
Johor Bahru
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Sultanah Aminah
City
Johor Bahru
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Kajang
City
Kajang
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Serdang
City
Kajang
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Tuanku Fauziah
City
Kangar
Country
Malaysia
Individual Site Status
Completed
Facility Name
Pusat Rawatan Dialisis Tuanku Syed Putra - NKF
City
Kangar
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Tengku Ampuan Rahimah
City
Klang
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Pusat Daillisis NKF - Kelab Apex
City
Klang
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Raja Perempuan Zainab II
City
Kota Bharu
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Likas
City
Kota Kinabalu
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Queen Elizabeth II
City
Kota Kinabalu
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Kuala Kangsar
City
Kuala Kangsar
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Kuala Lipis
City
Kuala Lipis
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Pusat Dialisis NKF-Fungates Superflow
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Pusat Dialisis NKF-Nanyang
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Universiti Kebangsaan Malaysia Medical Centre
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Tengku Ampuan Afzan
City
Kuantan
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Kudat
City
Kudat
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Kulim
City
Kulim
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Labuan
City
Labuan
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Sultanah Bahiyah
City
Langgar
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Haemodialysis Unit Klinik Kesihatan Lenggong
City
Lenggong
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Pusat Hemodialisis Komuniti Cheng
City
Malaka
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Pakar Sultanah Fatimah
City
Muar
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Seberang Jaya
City
Permatang Pauh
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Pusat Dialisis NKF - Chempaka
City
Petaling Jaya
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Shah Alam
City
Shah Alam
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Universiti Teknologi Mara
City
Shah Alam
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Sultan Abdul Halim
City
Sungai Petani
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Sungai Siput
City
Sungai Siput
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Tambunan
City
Tambunan
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Sultan Haji Ahmad Shah
City
Temerluh
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Barnet Satellite Unit
City
Barnet
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Edgware Satellite Unit
City
Edgware
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Mary Rankin Satellite Unit
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal London Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Newham Hospital
City
Plaistow
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32889978
Citation
See EJ, Polkinghorne KR. Volume management in haemodialysis patients. Curr Opin Nephrol Hypertens. 2020 Nov;29(6):663-670. doi: 10.1097/MNH.0000000000000642.
Results Reference
derived

Learn more about this trial

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

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