Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

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.

Conditions

• End-Stage Kidney Disease

Interventions

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.

Sponsors & Collaborators

• Australasian Kidney Trials Network

  collaborator NETWORK

• Australia & New Zealand Dialysis & Transplant Registry

  collaborator UNKNOWN

• The George Institute

  collaborator OTHER

• The George Institute for Global Health, China

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Institute for Clinical Evaluative Sciences

  collaborator OTHER

• St. Michaels Hospital

  collaborator UNKNOWN

• University Hospital Wuerzburg, Medizinische Klinik EINS

  collaborator UNKNOWN

• Malaysian Society of Nephrology

  collaborator UNKNOWN

• Malaysian Renal Registry

  collaborator UNKNOWN

• Comprehensive Clinical Trials Unit, University College London

  collaborator UNKNOWN

• University of Sydney

  lead OTHER

Principal Investigators

• Meg Jardine · The University of Sydney, NHMRC Clinical Trials Centre

• Carmel Hawley · The University of Queensland

• Vivekanand Jha · The George Institute India

• Zuo Li · Peking University People's Hospital

• Sunita Bavanandan · Kuala Lumpur General Hospital

• David Wheeler · Comprehensive Clinical Trials Unit, University College London

• Patrick Rossignol · INSERM Clinical Investigation Centre

• Mike Walsh · McMaster University

• Vlado Perkovic · University of New South Wales

• Christoph Wanner · University Hospital Wuerzburg

• Jule Pinter · University Hospital Wuerzburg

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Australia
• Canada
• Germany
• India
• Malaysia
• United Kingdom

Study Locations