RESOLVE: Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

Sponsor

University of Sydney (Other)

Overall Status

Recruiting

CT.gov ID

NCT02823821

Collaborator

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

50,000

Enrollment

117

Locations

Arms

102

Anticipated Duration (Months)

427.4

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End-Stage Kidney Disease	Other: Default dialysate sodium concentration of 137mmol/l Other: Default dialysate sodium concentration of 140mmol/l	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

Actual Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 137mmol/l Participating dialysis sites will be randomised to a default dialysate sodium concentration of 137mmol/l	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.
Active Comparator: 140mmol/l Participating dialysis sites will be randomised to a default dialysate sodium concentration of 140mmol/l	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.

Arm

Intervention/Treatment

Active Comparator: 137mmol/l

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

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.

Active Comparator: 140mmol/l

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

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Adelaide Hospital	Adelaide		Australia
2	Auburn Hospital	Auburn		Australia	2144
3	Moorabbin Hospital	Bentleigh East		Australia	3165
4	Princess Alexandra Hospital	Brisbane		Australia	4102
5	Redlands Hospital	Brisbane		Australia	4163
6	Bundaberg Hospital	Bundaberg		Australia
7	Caloundra Hospital	Caloundra		Australia	4551
8	The Canberra Hospital	Canberra		Australia
9	Peninsula Health	Frankston		Australia	3199
10	Gympie Hospital	Gympie		Australia	4570
11	Ipswich Hospital	Ipswich		Australia	4305
12	Mackay Base Hospital	Mackay		Australia
13	Logan Hospital	Meadowbrook		Australia	4131
14	Monash Health Community Dandenong	Melbourne		Australia	3175
15	Casey Hospital	Melbourne		Australia	3806
16	Cranbourne Integrated Care Centre	Melbourne		Australia	3977
17	Nambour General Hospital	Nambour		Australia	4560
18	Hampstead Dialysis Centre	Northfield		Australia
19	Hervey Bay Hospital	Pialba		Australia
20	Sunshine Coast University Hospital	Sunshine Coast		Australia	4575
21	Sydney Adventist Hospital	Sydney		Australia	2076
22	Concord Repatriation and General Hospital	Sydney		Australia	2139
23	Blacktown Regional Dialysis Centre	Sydney		Australia	2148
24	Mt Druitt Community Dialysis Centre	Sydney		Australia	2770
25	Nepean Hospital	Sydney		Australia
26	Westmead Hospital	Sydney		Australia
27	The Queen Elizabeth Hospital	Woodville South		Australia
28	Brantford General Hospital	Brantford	Ontario	Canada
29	Chatam-Kent Health Alliance	Chatham	Ontario	Canada
30	St Joseph's Healthcare	Hamilton	Ontario	Canada
31	Hanover District Hospital	Hanover	Ontario	Canada
32	Adam Linton Dialysis Unit - Victoria Hospital	London	Ontario	Canada
33	London Health Sciences Centre	London	Ontario	Canada
34	Westmount Kidney Care Centre	London	Ontario	Canada
35	Grey Bruce Health Services	Owen Sound	Ontario	Canada
36	Bluewater Hospital	Sarnia	Ontario	Canada
37	Huron Perth Hospital Partnership	Stratford	Ontario	Canada
38	Tillsonburg District Memorial Hospital	Tillsonburg	Ontario	Canada
39	Woodstock General Hospital	Woodstock	Ontario	Canada
40	Stoney Creek	Hamilton		Canada
41	Belleville	Kingston		Canada
42	Brockville	Kingston		Canada
43	Kingston General	Kingston		Canada
44	Napanee	Kingston		Canada
45	Perth and Smith Falls	Kingston		Canada
46	Picton	Kingston		Canada
47	St. Michael's Hospital	Toronto		Canada
48	Praxis für Nierenkrankheiten Berlin Hellersdorf	Berlin		Germany
49	Dialysezentrum Elsenfeld	Elsenfeld		Germany
50	Arbeitsgemeinschaft Heimdialyse Saar e.V.	Homburg		Germany
51	KfH Nierenzentrum Lichtenfels	Lichtenfels		Germany
52	Universitätsmedizin Mainz, Dialysestation 605-5E	Mainz		Germany
53	Dialysezentrum Schweinfurt	Schweinfurt		Germany
54	Nephrologisches Zentrum Villingen-Schwenningen -Tuttlingen	Villingen-Schwenningen		Germany	78052
55	Area Hospital, Kothapeta Road,Chirala, Andhra Pradesh	Chirala	Andhra Pradesh	India
56	Medical Superintendent Government Hospital	Gudur	Andhra Pradesh	India
57	Government General Hospital	Guntur	Andhra Pradesh	India
58	Medical Superintendent District Hospital	Hindupur PPP	Andhra Pradesh	India
59	Government Area Hospital, Kanigiri, Andhra Pradesh	Kanigiri	Andhra Pradesh	India
60	Government General Hospital	Kurnool	Andhra Pradesh	India
61	Government Hospital	Kākināda	Andhra Pradesh	India
62	Government Hospital, Machilipatnam PPP, Andhra Pradesh	Machilipatnam	Andhra Pradesh	India
63	Government Area Hospital	Markapur	Andhra Pradesh	India
64	Government Hospital	Nandyal	Andhra Pradesh	India
65	Area Hospital	Narsipatnam	Andhra Pradesh	India
66	Government Area Hospital	Palakonda, Srikakulam District	Andhra Pradesh	India
67	CHC Government Hospital	Palasa	Andhra Pradesh	India
68	Government Area Hospital	Parvathipuram	Andhra Pradesh	India
69	Government Hospital	Proddatur	Andhra Pradesh	India
70	Government Hospital	Rajahmundry	Andhra Pradesh	India
71	CHC Hospital, Sompeta, Andhra Pradesh	Sompeta	Andhra Pradesh	India
72	Greater Kailash Hospital	Tadepalligudem	Andhra Pradesh	India
73	Manasa Kidney Foundation	Tirupati	Andhra Pradesh	India
74	Government General Hospital, Vijayavada PPP, Andhra Pradesh	Vijayavada	Andhra Pradesh	India
75	King George Government Hospital	Visakhapatnam	Andhra Pradesh	India
76	Rajiv Gandhi Institute of Medical Sciences, Srikakulam PPP, Andhra	Srikakulam	Andhra	India
77	Ford Hospital, Khemnichak, Patna	Patna	Bihar	India
78	Janak Dulari Hospital, Hanuman Nagar	Patna	Bihar	India
79	Aysha Hospital	Kilpauk	Chennai	India
80	Retteri Sri Kumaran Health Centre	Kolathur	Chennai	India
81	Leelawati Hospital	Ambāla	Haryana	India
82	Greater Kailash Hospital	Old Palasia	Indore	India
83	ESI Hospital	Adityapur	Jharkand	India
84	K.M Memorial Hospital and Research Centre	Bokaro	Jharkhand	India
85	Asarfi Hospital	Dhanbad	Jharkhand	India
86	Bhagwan Mahavir Medical Superspeciality Hospital	Ranchi	Jharkhand	India
87	Guru Nanak Hospital and Research Centre	Ranchi	Jharkhand	India
88	Koshys Hospital, Ramamurthy Nagar	Bengaluru	Karnataka	India
89	Nephroplus Basaveshwaranagar	Bengaluru	Karnataka	India
90	Fortis Suchirayu Hospital	Hubli	Karnataka	India
91	Main Hospital, SCCL	Kothagudem	Khammam	India
92	Vishesh Hospital Pvt. Ltd, Geeta Bhawan Chouraha	Indore	Madhya Pradesh	India
93	Hitwardhak Mandal Hospital	Mumbai	Maharashtra	India
94	Lokmanya Hospital	Pune	Maharashtra	India
95	Chirayu Hospital	Thāne	Maharashtra	India
96	Nephroplus Borivali Standalone	Borivali West	Mumbai	India	400092
97	Bharat Baug	Borivali West	Mumbai	India
98	Jyothi Hospital	Balasore	Odisha	India
99	Kar Clinic & Hospital Pvt. Ltd.	Bhubaneswar	Odisha	India
100	Neelachal Hospital, Kharvel Nagar	Bhubaneswar	Odisha	India
101	Satguru Partap Singh Apollo Hospitals	Ludhiāna	Punjab	India
102	KG Hospital	Coimbatore	Tamil Nadu	India
103	Sudha Hospital, Vadalur	Neyveli	Tamil Nadu	India
104	Deepam Hospitals, Pallavaram	Chennai	Tamilnadu	India
105	Neyveli Lignite Corporation Hospital	Neyveli	Tamilnadu	India
106	Citizens Specialty Hospital	Hyderabad	Telangana	India
107	ESI Multi-Specialty Hospital	Hyderabad	Telangana	India
108	Vintage Plaza Nephroplus, Road no. 10, Banjara Hills	Hyderabad	Telangana	India
109	Government Hospital	Khammam	Telangana	India
110	Suraksha Multispecialty Hospital	Nalgonda	Telangana	India
111	Nephroplus Standalone Dialysis Center, Easy Marredpally	Secunderabad	Telangana	India
112	Madhuraj Hospital	Kanpur	Uttar Pradesh	India
113	Ajanta Hospital	Lucknow	Uttar Pradesh	India
114	Surbhi Hospital Pvt. Ltd, Sector 35	Noida	Uttar Pradish	India
115	Health Point Hospital, Prannth Pandit Street	Kolkata	West Bengal	India
116	Minimal Access Surgery Clinic Pvt Ltd	Tamluk	West Bengal	India
117	Baroma Sirona Hospital	Uttar Mechgram	West Bengal	India

Investigators

Principal Investigator: 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