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| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
| Baxter Healthcare Corporation | INDUSTRY |
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This study will assess clinical outcomes of extended weekly hours of haemodialysis (>= 24 hours per week) compared with standard hours of haemodialysis (<=18 hours/week) in people with ESKD.
A rapidly increasing volume of observational data suggests substantial benefits may be associated with an increased duration of dialysis. As well as improved quality of life, improved functioning and beneficial changes in a variety of laboratory parameters, it has been suggested that extended dialysis sessions might reduce mortality and major morbidity. Uncontrolled data from centres that have been providing extended dialysis shows dramatically lower mortality rates compared to those observed in centres providing standard duration dialysis. Recent analyses of extended dialysis conclude that the savings achieved in drug and hospitalization costs may lead to an overall reduction in costs compared with traditional forms of dialysis.
In this trial, we propose to examine the effects of extended dialysis (24 hours weekly or more) compared to standard dialysis (18 hours or less weekly) in patients with ESKD. The proposed study is a multi-centre, open label, randomised, controlled trial.
The study began with a pilot phase which was converted to the current main study on the receipt of peer-reviewed funding for the full study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| extended hours | Experimental | 24 or more hours per week of hemodialysis |
|
| standard hours | Active Comparator | 18 or less hours per week of hemodialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| haemodialysis | Procedure | Comparison of different weekly duration of haemodialysis treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary end-point for this study is the difference in the change in quality of life between the two groups from randomisation to the 12 month follow-up as measured by the EQ-5D instrument. | 12 months from randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Survival and cardiovascular analyses | 12 months | |
| Quality of life and patient acceptability | 12 months | |
| Safety outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vlado Perkovic, MBBS PhD | The George Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Canberra Hospital | Canberra | Australian Capital Territory | Australia | |||
| RPAH/Concord |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25529309 | Background | Jardine MJ, Zuo LI, Gray NA, de Zoysa J, Chan CT, Gallagher MP, Howard K, Hertier S, Cass A, Perkovic V; ACTIVE Dialysis Steering Committee. Design and participant baseline characteristics of 'A Clinical Trial of IntensiVE Dialysis': the ACTIVE Dialysis Study. Nephrology (Carlton). 2015 Apr;20(4):257-65. doi: 10.1111/nep.12385. | |
| 31672793 |
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| 12 months |
| Costs associated with each intervention | 12 months |
| Changes in biochemical and haematological parameters | 12 months |
| Sydney |
| New South Wales |
| 2050 |
| Australia |
| Sydney Adventist Hospital | Sydney | New South Wales | 2076 | Australia |
| Liverpool Hospital | Sydney | New South Wales | Australia |
| Sydney Dialysis Centre | Sydney | New South Wales | Australia |
| Princess Alexandra Hospital | Brisbane | Queensland | Australia |
| Royal Brisbane Hospital | Brisbane | Queensland | Australia |
| Gold Coast Hospital | Gold Coast | Queensland | Australia |
| Nambour General Hospital | Nambour | Queensland | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | Australia |
| Austin Hospital | Melbourne | Victoria | Australia |
| Monash Medical Centre | Melbourne | Victoria | Australia |
| Royal Melbourne Hospital | Melbourne | Victoria | Australia |
| Sir Charles Gairdner Hospital | Perth | Western Australia | Australia |
| UBC | Vancouver | British Columbia | Canada |
| St Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| University Health Network | Toronto | Ontario | Canada |
| Beijing Hospital of Traditional Chinese Medicine | Beijing | Beijing Municipality | China |
| Beijing Tongren Hospital | Beijing | Beijing Municipality | China |
| Civil Aviation General Hospital | Chaoyang District, | Beijing Municipality | China |
| China-Japan Friendship Hospital | Chaoyang District | Beijing Municipality | China |
| First Affiliated Hospital of Chinese PLA General Hospital | Haidian District | Beijing Municipality | China |
| Beijing Hospital | Xicheng District | Beijing Municipality | China |
| Peking University First Hospital | Xicheng District | Beijing Municipality | China |
| Peking University People's Hospital | Xicheng District | Beijing Municipality | China |
| Shenzhen Hospital of Peking University | Shenzhen | Guangdong | China |
| Fourth Hospital Affiliated to Hebei Medical University | Shijiazhuang | Hebei | China |
| Shijiazhuang First People's Hospital | Shijiazhuang | Hebei | China |
| Third Hospital Affiliated to Hebei Medical University | Shijiazhuang | Hebei | China |
| Zhengzhou University affiliated first hospital | Zhengzhou | Henan | China |
| First Affiliated Hospital of Inner Mongolia, Baotou Medical College | Baotou | Inner Mongolia | China |
| Zhongda Hospital, Southeast University | Nanjing | Jiangsu | China |
| Fourth Hospital Affiliated to Jilin University (FAW General Hospital) | Changchun | Jilin | China |
| Dalian Medical affiliated first hospital | Dalian | Liaoning | China |
| Shanghai Ruijin Hospital | Shanghai | Shanghai Municipality | China |
| The Chinese PLA Shanghai 85th Hospital | Shanghai | Shanghai Municipality | China |
| The second affiliated hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| Huaxi Hospital of Sichuan University | Chengdu | Sichuan | China |
| Auckland City Hospital | Auckland | New Zealand |
| North Shore Hospital | Auckland | New Zealand |
| Smyth B, van den Broek-Best O, Hong D, Howard K, Rogers K, Zuo L, Gray NA, de Zoysa JR, Chan CT, Lin H, Zhang L, Xu J, Cass A, Gallagher M, Perkovic V, Jardine M. Varying Association of Extended Hours Dialysis with Quality of Life. Clin J Am Soc Nephrol. 2019 Dec 6;14(12):1751-1762. doi: 10.2215/CJN.06800619. Epub 2019 Oct 31. |
| 28151412 | Result | Jardine MJ, Zuo L, Gray NA, de Zoysa JR, Chan CT, Gallagher MP, Monaghan H, Grieve SM, Puranik R, Lin H, Eris JM, Zhang L, Xu J, Howard K, Lo S, Cass A, Perkovic V; ACTIVE Dialysis Steering Committee; Paul. A Trial of Extending Hemodialysis Hours and Quality of Life. J Am Soc Nephrol. 2017 Jun;28(6):1898-1911. doi: 10.1681/ASN.2015111225. Epub 2017 Feb 1. |
| 31299919 | Result | Zhan Z, Smyth B, Toussaint ND, Gray NA, Zuo L, de Zoysa JR, Chan CT, Jin C, Scaria A, Hawley CM, Perkovic V, Jardine MJ, Zhang L. Effect of extended hours dialysis on markers of chronic kidney disease-mineral and bone disorder in the ACTIVE Dialysis study. BMC Nephrol. 2019 Jul 12;20(1):258. doi: 10.1186/s12882-019-1438-3. |
| 29424935 | Result | Liao JL, van den Broek-Best O, Smyth B, Hong D, Vo K, Zuo L, Gray NA, Chan CT, de Zoysa J, Perkovic V, Jiang L, Jardine M. Effect of extended hours dialysis on sleep quality in a randomized trial. Nephrology (Carlton). 2019 Apr;24(4):430-437. doi: 10.1111/nep.13236. |
| 30723975 | Result | Gray NA, Zuo L, Hong D, Smyth B, Jun M, De Zoysa J, Vo K, Howard K, Wang J, Lu C, Liu Z, Cass A, Perkovic V, Jardine M. Quality of life in caregivers compared with dialysis recipients: The Co-ACTIVE sub-study of the ACTIVE dialysis trial. Nephrology (Carlton). 2019 Oct;24(10):1056-1063. doi: 10.1111/nep.13530. Epub 2019 Apr 29. |
| 21388319 | Derived | Badve SV, Hawley CM, Johnson DW. Frequent versus standard hemodialysis. N Engl J Med. 2011 Mar 10;364(10):975; author reply 976. doi: 10.1056/NEJMc1100105. No abstract available. |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D014511 | Uremia |
| D017379 | Hypertrophy, Left Ventricular |
| D006973 | Hypertension |
| D000740 | Anemia |
| D002318 | Cardiovascular Diseases |
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001164 | Arteriovenous Fistula |
| D013927 | Thrombosis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D014652 | Vascular Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D017202 | Myocardial Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D016157 | Vascular Fistula |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D003956 | Dialysis |
| D017582 | Renal Replacement Therapy |
| ID | Term |
|---|---|
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D055598 | Chemical Phenomena |
| D013812 | Therapeutics |
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