- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00649298
A Clinical Trial of IntensiVE Dialysis (ACTIVE)
ACTIVE Dialysis - A Multicentre, Unblinded, Randomised, Controlled Trial to Assess Quality of Life, Clinical Outcomes and Cost Utility for Extended vs Standard Duration of Dialysis in Patients With End Stage Kidney Disease.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Auckland, 뉴질랜드
- Auckland City Hospital
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Auckland, 뉴질랜드
- North Shore Hospital
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Beijing
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Beijing, Beijing, 중국
- Beijing Tongren Hospital
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Beijing, Beijing, 중국
- Beijing Hospital of Traditional Chinese Medicine
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Chaoyang District, Beijing, 중국
- China-Japan Friendship Hospital
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Chaoyang District,, Beijing, 중국
- Civil Aviation General Hospital
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Haidian District, Beijing, 중국
- First Affiliated Hospital of Chinese PLA General Hospital
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Xicheng District, Beijing, 중국
- Beijing Hospital
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Xicheng District, Beijing, 중국
- Peking University First Hospital
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Xicheng District, Beijing, 중국
- Peking University People's Hospital
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Guangdong
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Shenzhen, Guangdong, 중국
- Shenzhen Hospital of Peking University
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Hebei
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Shijiazhuang, Hebei, 중국
- Fourth Hospital Affiliated to Hebei Medical University
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Shijiazhuang, Hebei, 중국
- Shijiazhuang First People's Hospital
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Shijiazhuang, Hebei, 중국
- Third Hospital Affiliated to Hebei Medical University
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Henan
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Zhengzhou, Henan, 중국
- Zhengzhou University affiliated first hospital
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Inner Mongolia
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Baotou, Inner Mongolia, 중국
- First Affiliated Hospital of Inner Mongolia, Baotou Medical College
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Jiangsu
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Nanjing, Jiangsu, 중국
- Zhongda Hospital, Southeast University
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Jilin
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Changchun, Jilin, 중국
- Fourth Hospital Affiliated to Jilin University (FAW General Hospital)
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Liaoning
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Dalian, Liaoning, 중국
- Dalian Medical affiliated first hospital
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Shanghai
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Shanghai, Shanghai, 중국
- Shanghai Ruijin Hospital
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Shanghai, Shanghai, 중국
- The Chinese PLA Shanghai 85th Hospital
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Shanxi
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Taiyuan City, Shanxi, 중국
- The Second Affiliated Hospital of Shanxi Medical University
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Sichuan
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Chengdu, Sichuan, 중국
- Huaxi Hospital of Sichuan University
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British Columbia
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Vancouver, British Columbia, 캐나다
- UBC
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Ontario
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Toronto, Ontario, 캐나다
- University Health Network
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Toronto, Ontario, 캐나다, M5B 1W8
- St Michael's Hospital
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Australian Capital Territory
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Canberra, Australian Capital Territory, 호주
- The Canberra Hospital
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New South Wales
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Sydney, New South Wales, 호주, 2076
- Sydney Adventist Hospital
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Sydney, New South Wales, 호주
- Liverpool Hospital
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Sydney, New South Wales, 호주, 2050
- RPAH/Concord
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Sydney, New South Wales, 호주
- Sydney Dialysis Centre
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Queensland
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Brisbane, Queensland, 호주
- Princess Alexandra Hospital
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Brisbane, Queensland, 호주
- Royal Brisbane Hospital
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Gold Coast, Queensland, 호주
- Gold Coast Hospital
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Nambour, Queensland, 호주
- Nambour General Hospital
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Tasmania
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Hobart, Tasmania, 호주
- Royal Hobart Hospital
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Victoria
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Melbourne, Victoria, 호주
- Royal Melbourne Hospital
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Melbourne, Victoria, 호주
- Austin Hospital
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Melbourne, Victoria, 호주
- Monash Medical Centre
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Western Australia
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Perth, Western Australia, 호주
- Sir Charles Gairdner Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Incident or prevalent patients requiring maintenance haemodialysis therapy for ESKD
- Aged 18 years or older
- Undergoing dialysis for 18 hours per week or less
- Suitable for either extended or standard dialysis in the view of the treating physician
- Agreeable to randomisation
Exclusion Criteria:
- Life expectancy of less than 6 months
- Definite plans to undergo renal transplantation within 12 months of entry to the study
- Inability to complete quality of life questionnaire
- Concomitant major illness that would limit assessments and followup
- High chance that the patient will not adhere to study treatment and follow up in the view of the treating physician.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: extended hours
24 or more hours per week of hemodialysis
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Comparison of different weekly duration of haemodialysis treatment
다른 이름들:
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활성 비교기: standard hours
18 or less hours per week of hemodialysis
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Comparison of different weekly duration of haemodialysis treatment
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
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.
기간: 12 months from randomisation
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12 months from randomisation
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2차 결과 측정
결과 측정 |
기간 |
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Survival and cardiovascular analyses
기간: 12 months
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12 months
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Quality of life and patient acceptability
기간: 12 months
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12 months
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Safety outcomes
기간: 12 months
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12 months
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Costs associated with each intervention
기간: 12 months
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12 months
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Changes in biochemical and haematological parameters
기간: 12 months
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Vlado Perkovic, MBBS PhD, The George Institute
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
- 전염병
- 뇌졸중
- 심혈관 질환
- 삶의 질
- 고혈압
- 빈혈증
- 혈액학
- 무작위 대조 시험
- 혈전증
- 인류
- 임상 시험
- 혈압
- 급성관상동맥증후군
- 혈액 투석
- 심근 경색증
- 연장된 투석
- 신장 대체 요법
- 신장 투석
- 입원
- 다기관 연구
- 뇌혈관 장애
- 비대, 좌심실
- 동정맥루
- 통제된 임상 시험
- 비용 분석
- 말기 신장 질환
- 경제성 평가
- 건강 관리 비용
- 적혈구 생성 자극제
- 건강 지출
- Clinical Trial, Phase IV
- Nocturnal Dialysis
- Quality Adjusted Life Year
- Cost-utility Analysis
- Health Care Utilisation
- Arteriovenous Shunt, Surgical
기타 연구 ID 번호
- GI-R-A001- 09
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .