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Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation (ADIFE)

Primary Purpose

Chronic Kidney Disease

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
optimal start time
late start time
Sponsored by
The First Affiliated Hospital of Dalian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring end-stage renal disease, timing of dialysis initiation, hemodialysis, fuzzy mathematics, glomerular filtration rate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • the First Affiliated Hospital of Dalian Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

optimal start dialysis group

late start dialysis group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

all-cause mortality
proportion of patients who die from any cause
cerebro-cardiovascular mortality
proportion of patients who die from cerebro-cardiovascular disease

Secondary Outcome Measures

cerebro-cardiovascular events
proportion of patients who suffer from cardiovascular events, which include nonfatal myocardial infarction, nonfatal stroke, transient ischemic attack,new-onset angina, acute heart failure or severe arrhythmia.
hospitalization
proportion of patients admitted to hospital
Nutrition assessment
assess the patient's nutritional status by subjective global assessment (SGA) assessment and serum albumin level
the change of quality of life
use short form-36 reported by the patients to assess the patient's quality of life
Medical cost
the cost by the patient, family and insurance during treatment
Hemodialysis complications
the proportion of patients who suffer from hemodialysis complications including blood assess revise, assess infection, severe fluid and electrolyte disorders
cognitive dysfunction
assess cognitive dysfunction by Montreal Cognitive Assessment (MoCA)

Full Information

First Posted
December 21, 2017
Last Updated
April 15, 2022
Sponsor
The First Affiliated Hospital of Dalian Medical University
Collaborators
Chinese PLA General Hospital, Fudan University, RenJi Hospital, Guangdong Provincial People's Hospital, Beijing Friendship Hospital, Huashan Hospital, West China Hospital, First Affiliated Hospital, Sun Yat-Sen University, Chinese Academy of Medical Sciences, Fuwai Hospital, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, General hospital of benxi iron and steel co., Dalian Municipal Central Hospital, An Steel Group Hospital, The First Affiliated Hospital of the Fourth Military Medical University, General Hospital of Mining Industry Group Fuxin, The Affiliated Zhongshan Hospital of Dalian University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, General Hospital of Ningxia Medical University, LanZhou University, First Affiliated Hospital Xi'an Jiaotong University, Henan Provincial People's Hospital, First Affiliated Hospital of Xinjiang Medical University, First Hospital of China Medical University, Central hospital affiliated to shenyang medical college
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1. Study Identification

Unique Protocol Identification Number
NCT03385902
Brief Title
Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation
Acronym
ADIFE
Official Title
Impact on Mortality of Timing of Dialysis Initiation in Patients With End-stage Renal Disease by a Novel Assessment Based on Fuzzy Mathematics
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 14, 2018 (Actual)
Primary Completion Date
August 14, 2023 (Anticipated)
Study Completion Date
December 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Dalian Medical University
Collaborators
Chinese PLA General Hospital, Fudan University, RenJi Hospital, Guangdong Provincial People's Hospital, Beijing Friendship Hospital, Huashan Hospital, West China Hospital, First Affiliated Hospital, Sun Yat-Sen University, Chinese Academy of Medical Sciences, Fuwai Hospital, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, General hospital of benxi iron and steel co., Dalian Municipal Central Hospital, An Steel Group Hospital, The First Affiliated Hospital of the Fourth Military Medical University, General Hospital of Mining Industry Group Fuxin, The Affiliated Zhongshan Hospital of Dalian University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, General Hospital of Ningxia Medical University, LanZhou University, First Affiliated Hospital Xi'an Jiaotong University, Henan Provincial People's Hospital, First Affiliated Hospital of Xinjiang Medical University, First Hospital of China Medical University, Central hospital affiliated to shenyang medical college

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The optimal time of dialysis initiation is still controversial. Estimated glomerular filtration rate (eGFR) which is now widely used as the assessment of timing of dialysis is lack of specificity. Some clinical factors such as heart failure, volume overload, malnutrition also determine the dialysis time. But these subjective judgements do not have a standard. So there is no quantitative assessment of timing of dialysis initiation. The research team developed a novel equation named DIFE (Dialysis Initiation based on Fuzzy mathematics Equation) with data from a retrospective multicenter cohort by fuzzy mathematical methods to combine these clinical factors and lab indexes. The DIFE was confirmed to be more accurate and convenient to use in clinical practice than eGFR only at the assessment of dialysis initiation time in the internal validation. For further validation of the DIFE, the team will conduct a multicenter randomized controlled trial. Patients who need hemodialysis will be randomized to optimal start dailysis group or late start dailysis group by the assessment of the DIFE. Based on the comparison of the two groups, this trial will provide evidence for the optimal timing of dialysis initiation in patients with end-stage renal disease by the DIFE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
end-stage renal disease, timing of dialysis initiation, hemodialysis, fuzzy mathematics, glomerular filtration rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
388 (Actual)

8. Arms, Groups, and Interventions

Arm Title
optimal start dialysis group
Arm Type
Experimental
Arm Description
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.
Arm Title
late start dialysis group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
optimal start time
Intervention Description
patients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30.
Intervention Type
Other
Intervention Name(s)
late start time
Intervention Description
patients will start hemodialysis when their DIFE less than 30
Primary Outcome Measure Information:
Title
all-cause mortality
Description
proportion of patients who die from any cause
Time Frame
from the date of enrollment until the end of study, assessed up to 3 years
Title
cerebro-cardiovascular mortality
Description
proportion of patients who die from cerebro-cardiovascular disease
Time Frame
3 years, from the date of enrollment until the end of study
Secondary Outcome Measure Information:
Title
cerebro-cardiovascular events
Description
proportion of patients who suffer from cardiovascular events, which include nonfatal myocardial infarction, nonfatal stroke, transient ischemic attack,new-onset angina, acute heart failure or severe arrhythmia.
Time Frame
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
Title
hospitalization
Description
proportion of patients admitted to hospital
Time Frame
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
Title
Nutrition assessment
Description
assess the patient's nutritional status by subjective global assessment (SGA) assessment and serum albumin level
Time Frame
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
Title
the change of quality of life
Description
use short form-36 reported by the patients to assess the patient's quality of life
Time Frame
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
Title
Medical cost
Description
the cost by the patient, family and insurance during treatment
Time Frame
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
Title
Hemodialysis complications
Description
the proportion of patients who suffer from hemodialysis complications including blood assess revise, assess infection, severe fluid and electrolyte disorders
Time Frame
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
Title
cognitive dysfunction
Description
assess cognitive dysfunction by Montreal Cognitive Assessment (MoCA)
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongli Lin, MD， PhD
Organizational Affiliation
The First Affiliated Hospital of Dalian Medical University
Official's Role
Study Director
Facility Information:
Facility Name
the First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20581422
Citation
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.
Results Reference
background
PubMed Identifier
24508475
Citation
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.
Results Reference
result
PubMed Identifier
22465328
Citation
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.
Results Reference
result
PubMed Identifier
24492525
Citation
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.
Results Reference
result
PubMed Identifier
24652801
Citation
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.
Results Reference
result
PubMed Identifier
20519231
Citation
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.
Results Reference
result
PubMed Identifier
31501092
Citation
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.
Results Reference
derived

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Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation

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