Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation
NCT ID: NCT03385902
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
388 participants
INTERVENTIONAL
2018-04-14
2023-12-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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optimal start dialysis group
The DIFE will be used as the assessment of initiation time of dialysis. Patients in this group will start dialysis when their results of the DIFE reaching to 30-35, which defined as the optimal start time.
optimal start time
patients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30.
late start dialysis group
the DIFE will be used as the assessment of initiation time of dialysis. Patients in this group will start dialysis when their results of the DIFE less than 30, which defined as late start time.
late start time
patients will start hemodialysis when their DIFE less than 30
Interventions
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optimal start time
patients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30.
late start time
patients will start hemodialysis when their DIFE less than 30
Eligibility Criteria
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Inclusion Criteria
* Expected to commence maintenance hemodialysis as their renal replacement treatment
* Agreeable to randomization
Exclusion Criteria
* With the primary disease of systemic lupus erythematosus (SLE) or systemic vasculitis
* Have received or planning to receive a kidney transplant or peritoneal dialysis during the study
* Has a recently diagnosed cancer that was likely to affect survival (except for the following cases: the cancer has been confirmed to be cured or relieved for over 5 years, have had the radical resection for the basal cell carcinoma or squamous carcinoma of skin or carcinoma in-situ of any part of the body )
* Hepatocirrhosis
* Positive test of Human Immunodeficiency Virus (HIV), the hepatitis B virus antigen (HBsAg) or anti-hepatitis C virus antibody (HCV Ab)
* Acute infection within 1 month
* Bad habit which is difficult to withdrawal such as alcohol abuse
* Poor compliance and could not be treated according to the protocol
* Being pregnant, nursing or having a plan for pregnancy
* Life expectancy less than 1 year
* The investigator confirm that should not enroll in the study with any other cases
18 Years
75 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Fudan University
OTHER
RenJi Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
Beijing Friendship Hospital
OTHER
Huashan Hospital
OTHER
West China Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
General hospital of benxi iron and steel co.
UNKNOWN
Dalian Municipal Central Hospital
OTHER
An Steel Group Hospital
UNKNOWN
The First Affiliated Hospital of the Fourth Military Medical University
OTHER
General Hospital of Mining Industry Group Fuxin
UNKNOWN
Affiliated Zhongshan Hospital of Dalian University
OTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
OTHER
General Hospital of Ningxia Medical University
OTHER
LanZhou University
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Henan Provincial People's Hospital
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
First Hospital of China Medical University
OTHER
Central Hospital Affiliated to Shenyang Medical Collage
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
Responsible Party
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Principal Investigators
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Hongli Lin, MD， PhD
Role: STUDY_DIRECTOR
The First Affiliated Hospital of Dalian Medical University
Locations
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the First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Countries
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References
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Cooper BA, Branley P, Bulfone L, Collins JF, Craig JC, Fraenkel MB, Harris A, Johnson DW, Kesselhut J, Li JJ, Luxton G, Pilmore A, Tiller DJ, Harris DC, Pollock CA; IDEAL Study. A randomized, controlled trial of early versus late initiation of dialysis. N Engl J Med. 2010 Aug 12;363(7):609-19. doi: 10.1056/NEJMoa1000552. Epub 2010 Jun 27.
Crews DC, Scialla JJ, Boulware LE, Navaneethan SD, Nally JV Jr, Liu X, Arrigain S, Schold JD, Ephraim PL, Jolly SE, Sozio SM, Michels WM, Miskulin DC, Tangri N, Shafi T, Wu AW, Bandeen-Roche K; DEcIDE Network Patient Outcomes in End Stage Renal Disease Study Investigators. Comparative effectiveness of early versus conventional timing of dialysis initiation in advanced CKD. Am J Kidney Dis. 2014 May;63(5):806-15. doi: 10.1053/j.ajkd.2013.12.010. Epub 2014 Feb 6.
Susantitaphong P, Altamimi S, Ashkar M, Balk EM, Stel VS, Wright S, Jaber BL. GFR at initiation of dialysis and mortality in CKD: a meta-analysis. Am J Kidney Dis. 2012 Jun;59(6):829-40. doi: 10.1053/j.ajkd.2012.01.015. Epub 2012 Apr 1.
Nesrallah GE, Mustafa RA, Clark WF, Bass A, Barnieh L, Hemmelgarn BR, Klarenbach S, Quinn RR, Hiremath S, Ravani P, Sood MM, Moist LM; Canadian Society of Nephrology. Canadian Society of Nephrology 2014 clinical practice guideline for timing the initiation of chronic dialysis. CMAJ. 2014 Feb 4;186(2):112-7. doi: 10.1503/cmaj.130363. No abstract available.
Sood MM, Komenda P, Rigatto C, Hiebert B, Tangri N. The association of eGFR reporting with the timing of dialysis initiation. J Am Soc Nephrol. 2014 Sep;25(9):2097-104. doi: 10.1681/ASN.2013090953. Epub 2014 Mar 20.
Hwang SJ, Yang WC, Lin MY, Mau LW, Chen HC; Taiwan Society of Nephrology. Impact of the clinical conditions at dialysis initiation on mortality in incident haemodialysis patients: a national cohort study in Taiwan. Nephrol Dial Transplant. 2010 Aug;25(8):2616-24. doi: 10.1093/ndt/gfq308. Epub 2010 Jun 2.
Chen J, Liu Y, Chen X, Sun X, Li W, Yang W, Li P, Sun X, Wang D, Jiang H, Shi W, Liu W, Fu P, Ding X, Chang M, Liu S, Yang X, Cao N, Chen M, Ni Z, Chen J, Sun S, Liang X, Wang H, He Y, Gao B, Wang J, Hao L, Liu J, Li S, He Q, Liu H, Yi N, Shao F, Jiao J, Ma Y, Yao L, Sun Y, Li D, Szczech L, Fang M, Odeh Z, Lin H. Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial. BMJ Open. 2019 Sep 8;9(9):e023162. doi: 10.1136/bmjopen-2018-023162.
Other Identifiers
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YJ-KY-2017-119
Identifier Type: -
Identifier Source: org_study_id
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