NCT03385902

Brief Summary

The purpose of this study is to evaluate the impact of the optimal and late initiation of dialysis on the mortality and quality of life in end-stage renal disease (ESRD) patients by the Dialysis Initiation based on Fuzzy mathematics Equation (DIFE), which is a novel equation for the assessment of timing of dialysis initiation established by Fuzzy mathematics.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
388

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

April 14, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2023

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

5.3 years

First QC Date

December 21, 2017

Last Update Submit

April 15, 2022

Conditions

Chronic Kidney Disease

Keywords

end-stage renal diseasetiming of dialysis initiationhemodialysisfuzzy mathematicsglomerular filtration rate

Outcome Measures

Primary Outcomes (2)

  • all-cause mortality

    proportion of patients who die from any cause

    from the date of enrollment until the end of study, assessed up to 3 years

  • cerebro-cardiovascular mortality

    proportion of patients who die from cerebro-cardiovascular disease

    3 years, from the date of enrollment until the end of study

Secondary Outcomes (7)

  • cerebro-cardiovascular events

    from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years

  • hospitalization

    from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years

  • Nutrition assessment

    from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years

  • the change of quality of life

    from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years

  • Medical cost

    from the date of enrollment until the date of death from any cause, or the end of study, which ever came first, assessed up to 3 years

  • +2 more secondary outcomes

Study Arms (2)

optimal start dialysis group

EXPERIMENTAL

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.

Other: optimal start time

late start dialysis group

ACTIVE COMPARATOR

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.

Other: late start time

Interventions

optimal start timeOTHER

patients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30.

optimal start dialysis group
late start timeOTHER

patients will start hemodialysis when their DIFE less than 30

late start dialysis group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have progressive chronic kidney disease with an eGFR less than 15 ml/min/1.73m2 and a DIFE between 30-35
  • Expected to commence maintenance hemodialysis as their renal replacement treatment
  • Agreeable to randomization

You may not qualify if:

  • Acute kidney injury (AKI) or AKI on chronic kidney disease (CKD)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Related Publications (7)

  • 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.

    PMID: 20581422BACKGROUND

  • 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.

    PMID: 24508475RESULT

  • 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.

    PMID: 22465328RESULT

  • 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.

    PMID: 24492525RESULT

  • 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.

    PMID: 24652801RESULT

  • 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.

    PMID: 20519231RESULT

  • 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.

    PMID: 31501092DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hongli Lin, MD， PhD

    The First Affiliated Hospital of Dalian Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2017

First Posted

December 29, 2017

Study Start

April 14, 2018

Primary Completion

August 14, 2023

Study Completion

December 14, 2023

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)