The IDEAL Study
A Randomized, Controlled Trial of Early versus Late Initiation of Dialysis
Article published at www.nejm.org 27 June 2010
(10.1056/NEJMoa1000552) Bruce A Cooper, MB, BS, PhD, Pauline Branley BMed, PhD, Liliana Bulfone B.Pharm, MBA, John F Collins MB, ChB, Jonathan C Craig, MB, Ch.B, PhD, Margaret B Fraenkel, BM, BS, PhD, Anthony Harris, MA, MSc, David W Johnson, MB, BS, PhD, Joan Kesselhut, Jing Jing Li, BPharm, BCom., Grant Luxton, MB, BS, Andrew Pilmore, BSc, David J Tiller, MB, BS, David C Harris, MB, BS, MD, Carol A Pollock, MB, BS, PhD, for the IDEAL Study
Background: In clinical practice, there is considerable variation in the timing of the initiation of maintenance dialysis for patients with stage V chronic kidney disease, with a worldwide trend toward early initiation. In this study, conducted at 32 centers in Australia and New Zealand, we examined whether the timing of the initiation of maintenance dialysis influenced survival among patients with chronic kidney disease.
Conclusions: In this study, planned early initiation of dialysis in patients with stage V chronic kidney disease was not associated with an improvement in survival or clinical outcomes. (Australian New Zealand Clinical Trials Registry number 12609000266268)
The Initiation of Renal-Replacement Therapy — Just-in-Time Delivery
Associated editorial on the IDEAL Study www.nejm.org 27 June 2010
(10.1056/NEJMe1006669) Norbert Lameire MD PhD, and Wim Van Biesen MD, PhD
Conclusions: The main conclusion of this important study - that for asymptomatic patients renal-replacement therapy can be delayed by an average of 6 months - should be placed in perspective. An important prerequisite for a "wait and see" policy is careful clinical follow-up of each patient in order to avoid some of the life-threatening complications of uremia that may necessitate immediate renal-replacement therapy. All the patients in the trial had been followed for some time by their respective nephrologists and were well prepared to start dialysis.
The study protocol explicitly advocated that the method of dialysis be selected, and a functioning peritoneal or vascular access be prepared, in advance, a policy that permits the immediate initiation of dialysis if the patient becomes symptomatic. Indeed, few patients in either group started dialysis with the use of a temporary access catheter. Conversely, the results of the study also imply that among asymptomatic patients, delaying the start of dialysis until a permanent access has been created does not jeopardize the outcome. Given the results of the study, the use of temporary catheters, with their high risks of infection and stenosis, can probably be avoided, and patients willing to start peritoneal dialysis can avoid temporary hemodialysis.
Editorial conclusions: A Randomized, Controlled Trial of Early versus Late Initiation of Dialysis - The IDEAL Study supports the currently recommended practice, in which most nephrologists start patients on renal-replacement therapy on the basis of clinical factors rather than numerical criteria such as the estimated GFR alone. Early referral to a nephrologist, a well-organized patient-education program, and careful planning before dialysis is initiated are the cornerstones of such a strategy.
Other major research projects to the professional kidney community
Within Renal Division of The George Institute
- The Burden of Chronic Kidney Disease
Kidney Health Australia funded study examining the economic burden of kidney disease in Australia and exploring the cost-effective.
- The IMPAKT Study Improving Health Service Delivery and Outcomes for Indigenous Australians with Kidney Disease Funded by three-year project grant from the NHMRC, examines how health systems in different Australian states provide transplant services to kidney patients. It has a particular focus on the experience of Aboriginal and Torres Strait Islanders who have ESKD, and their ability to access and use transplant services.
- The Kanyini Vascular Collaboration
Improving health outcomes for Aboriginal and Torres Strait Islander Australians with chronic disease through strategies to reduce systems barriers to necessary care. Also see GI weblink and info on this study.
- The RENAL Study RCT of Normal vs. Augmented Level of Renal Replacement Therapy in ICU
NHMRC funded multi-centre clinical trial of intensive vs. normal continuous renal replacement therapy in acute renal failure in the ICU setting. This study is being undertaken in collaboration with the Australia and New Zealand Intensive Care Society Clinical Trial Group.
- The SHARP Study Study of Heart and Renal Protection
Global clinical trial of lipid-lowering in chronic kidney disease. The GI Renal Division co-ordinates this study in the Australasian region.
Other useful data references
Screening for chronic kidney disease in Australia: a pilot study in the community and workplace
Kidney International (2010) 77 (Suppl 116), S9–S16; doi:10.1038/ki.2009.538 - Timothy Mathew1 Olivia Corso1 Marie Ludlow1 Adam Boyle1 Alan Cass 2,3 Steven Chadban3,4 Beres Joyner5 Mark Shephard6 and Tim Usherwood 3
Presents major findings from our KEY Health Check Program - pilot study
Abstract The pilot program Kidney Evaluation for You (KEY) was conducted in Australia to screen for chronic kidney disease (CKD). Targeting people at high risk (those with diabetes, hypertension, a first-degree relative with kidney failure, or age >50 years), KEY aimed to establish community-based screening protocols, assess efficacy in promoting changes in risk-factor management, and explore participant CKD awareness.
KEY offered free cardiovascular and kidney checks using point-of-care testing for on-site pathology measurements (estimated glomerular filtration rate, hemoglobin A1c, cholesterol, hemoglobin, albuminuria), lifestyle assessment, and exit interviews. Participants were phoned at 3 months to ascertain whether KEY advice had been followed. Community and health professional support was strong; 99% of participants rated involvement as beneficial. Of 402 high-risk individuals recruited, findings were suggestive of CKD in 20.4%. Of these, 69% had hypertension, 30% diabetes, and 40% elevated total cholesterol. All participants with CKD stage 3b or higher were aged >61 years. Overall, 58% of participants were referred to their primary care providers for further action; of these, 82% saw their doctors in the next 3 months and 94% discussed KEY results.
Follow-up telephone contact was successful for 82% of participants. A change in management occurred for 67%. Thus, the KEY approach to early detection of CKD and selected referral of participants was largely successful.
Correspondence: Dr Tim Mathew, Level 1, 25 North Tce, Hackney SA 5069 Australia tim.mathew@kidney.org.au
1 Kidney Health Australia, Adelaide, Sth Australia, Australia
2 George Institute for International Health, Sydney, Australia
3 University of Sydney, New South Wales, Sydney, Australia
4 Department of Renal Medicine, Royal Prince Alfred Hospital, Sydney, Australia
5 Department of Rehabilitation and Aged Care, Central Queensland Health District, Queensland Australia
6 Community Point-of-Care Services, Flinders University Rural Clinical School, Sth Australia Australia
Review article: Early detection of chronic kidney disease in Australia: Which way to go?
Dr Timothy Mathew 1 and Miss Olivia Corso 2
1Kidney Health Australia, Medical Section, Kent Town Sth Australia
2Kidney Health Australia, Health Services, Adelaide Sth Australia
Kidney Health Australia conducted a 12-month pilot study on CKD, with funding from BHP Billiton and Commonwealth Department of Health and Ageing. The KEY Health Check was launched in February 2008 and recruited over 400 participants from three diverse Australian communities (Townsville, Roxby Downs, and Perth) who were offered a free and comprehensive evaluation of kidney function, cardiovascular health and diabetes risk.
Guidelines for the assessment of absolute cardiovascular disease risk (2009)
© 2009 National Heart Foundation of Australia ISBN: 978-1-921226-40-3 CON-064
For heart health information - 1300 362 787 www.heartfoundation.org.au
If you need to measure your patients’ five-year risk of getting CVD, use the CVD Risk Calculator from www.cvdcheck.org.au where you will also find:
- a downloadable desktop version of the same calculator
- easy-to-understand information explaining absolute CVD risk and what a risk score means
- a Q&A page that addresses frequently asked questions about absolute CVD risk
- links to other useful resources for measuring CVD risk and preventing CVD
The guidelines for the assessment of absolute cardiovascular disease risk have been endorsed by the National Health and Medical Research Council, absolute risk as defined in these guidelines is the numerical probability of a cardiovascular event occurring within a five-year period. It reflects a person’s ‘individualised’ risk of cardiovascular disease (CVD), recommendations adults aged 45-74 years (35 years and above for Aboriginal or Torres Strait Islander adults).
They feature sections on assessing adults - without known CVD, with diabetes or chronic kidney disease and who are overweight or obese. Clinical decisions based on absolute risk can lead to improved health outcomes by identifying people most at risk and directing the right treatments to them.
Quick links for Health Professionals
- Absolute cardiovascular disease risk assessment - quick reference guide for health professionals
- Australian cardiovascular risk charts (for optimal clarity and use, print these charts in colour)
- Absolute cardiovascular disease risk.Technical report: review of evidence and evidence-based recommendations for practice
*Initiative of National Vascular Disease Prevention Alliance - Diabetes Australia, Kidney Health Australia, National Heart Foundation of Australia and National Stroke Foundation © Approved by the National Health and Medical Research Council.
National Evidence Based Guideline for Patient Education in type 2 Diabetes (DM2) 2009
Colagiuri R, Girgis S, Eigenmann C, Gomez M, Griffiths R. National Evidenced Based Guideline for Patient Education in Type 2 Diabetes. Diabetes Australia and the NHMRC Canberra 2009
This guideline covers issues relating to patient education in adults with type 2 diabetes. It aims to inform and guide health care providers with evidence based information about what educational strategies and areas that have been shown to improve patient outcomes. The guideline targets health care professionals and all providers who deliver education to people with type 2 diabetes.
How can we achieve global equity in provision of Renal Replacement Therapy?
Volume 86, Number 3, March 2008, 161-240 Published in the World Health Organisation (W.H.O) Bulletin
Sarah L White a, Steven J Chadban b, Stephen Jan a, Jeremy R Chapman c, Alan Cass a
a. The George Institute for International Health, Royal Prince Alfred Hospital, Missenden Road, Sydney, NSW Australia
b. Central Clinical School, Faculty of Medicine, University of Sydney, Sydney, NSW Australia
c. Centre for Transplant and Renal Research, Westmead Millennium Institute, Westmead Hospital, Westmead NSW Australia
Conclusions: The global burden of ESKD is concealed behind statistics which reflect only the number of people treated, not those who die of kidney failure or cardiovascular complications. This is particularly the case for LMIC, where resources to provide RRT are severely limited and where substantial underreporting of ESKD probably reflects a vast unmet need. Attention to both the prevention and management of ESKD is required.
Successful RRT programs have been established in select LMICs, and are testament to the viability of such programs with the appropriate mix of local factors. Dialysis and transplant services need to be affordable, cost-effective and suited to local circumstances. The economic and quality-of-life advantages of transplantation make it an attractive modality over dialysis, and coordinated efforts to facilitate safe and ethical transplantation in LMIC are underway. Overall, global equity in provision of RRT will only be achieved through extensive public, patient and provider education, effective public policy, and ongoing support from international professional bodies, government and nongovernmental organizations.
Caring for Kidneys in the Antipodes: How Australia and New Zealand have addressed the challenge of End-Stage Renal Failure
Volume 53, Issue 3, Pages 536-545 (March 2009) Renal Unit - Concord Hospital and Dept Medicine, University of Sydney, NSW Australia All correspondence to A/ Prof Charles George MB, BS, MSc, PhD, FRACP, Renal Unit-Concord Hospital NSW
Clinicians in Australia and New Zealand have developed active programs for the treatment of patients with chronic renal disease, including end-stage renal failure. They became interested in treatment with dialysis and transplantation shortly after the initiation of these treatments elsewhere in the world and have distinguished themselves over the decades by striving to provide comprehensive treatment for all who appeared suitable on purely medical grounds, without patients' personal, financial, or social characteristics entering into consideration, and despite geographic and national economic impediments.
They have undertaken all major forms of treatment promptly after the development of these internationally and have conducted significant research locally. Home hemodialysis and peritoneal dialysis have featured more prominently in their repertoire than has been the case in many other countries, whereas in transplantation, they have traditionally shown a strong interest in the sourcing of grafts from deceased donors. Their participation in the field of end-stage renal failure has benefited from long-standing institutional support not only at the level of the governments and legal systems of their 2 countries, but also through the collegiality generated by their active participation in many local and international scientific societies.
Public Health Strategies in 2009 (USA)
Comprehensive Public Health Strategies for Preventing the Development, Progression, and Complications of CKD: Report of an Expert Panel Convened by the Centers for Disease Control and Prevention (CDC)
American Journal of Kidney Diseases Vol 53 No 3 (March) 2009: pp 522-535
At the request of the CDC, the expert panel reviewed the current state, evidence, and issues related to CKD and recommended a comprehensive public health strategy to prevent the development, progression, and complications of CKD in the United States. The strategy focuses on primary, secondary, and tertiary prevention initiatives; targets people with CKD and at increased risk of developing CKD; and encourages integration of activities of multiple organizations with responsibility for public health activities for patients with chronic diseases. This strategy can be translated locally and globally to improve outcomes for CKD.
Quick links - KHA webpages noting our publications and other reports of interest
Australian CKD Summit I Australian CKD Statistics I eGFR Tools inc eGFR Calculator I
Kidney Check Australia Taskforce (KCAT) I CARI Guidelines
Quick links - Kidney Health Australia Patient Education Resources
Health Fact Sheets I Health Publications I Organ Donation
Kidney Health News Bulletin - for Health Professionals
This bulletin brings you clinical and non clinical information from the kidney world and updates on our professional programs. Subscribe to joanna.stoic@kidney.org.au providing your name, professional details, city, state, country and interest in CKD.
Updated 22 July 2010
Disclaimer: This information is intended as a general introduction to this topic and is not meant to substitute for your doctor's or health professional's advice. All care is taken to ensure the information is relevant and applicable to each Australian state. It should be noted Kidney Health Australia recognises each person's experience is individual and variations do occur in treatment and management due to personal circumstances. Should you require further info always consult your doctor or health professional. |