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

May 5, 2026 updated by: Lin Hongli, The First Affiliated Hospital of Dalian Medical University

Impact on Mortality of Timing of Dialysis Initiation in Patients With End-stage Renal Disease by a Novel Assessment Based on Fuzzy Mathematics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

388

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • The First Affiliated Hospital of Dalian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: optimal start time
patients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30.
Active Comparator: 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.
Other: late start time
patients will start hemodialysis when their DIFE less than 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality
Time Frame: from the date of enrollment until the end of study, assessed up to 3 years
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
Time Frame: 3 years, from the date of enrollment until the end of study
proportion of patients who die from cerebro-cardiovascular disease
3 years, from the date of enrollment until the end of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cerebro-cardiovascular events
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
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.
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
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
proportion of patients admitted to hospital
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
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
assess the patient's nutritional status by subjective global assessment (SGA) assessment and serum albumin level
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
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
use short form-36 reported by the patients to assess the patient's 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
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
the cost by the patient, family and insurance during treatment
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
Hemodialysis complications
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
the proportion of patients who suffer from hemodialysis complications including blood assess revise, assess infection, severe fluid and electrolyte disorders
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
cognitive dysfunction
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
assess cognitive dysfunction by Montreal Cognitive Assessment (MoCA)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Dalian Medical University

Collaborators

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

Investigators

  • Study Director: Hongli Lin, MD， PhD, The First Affiliated Hospital of Dalian Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2018

Primary Completion (Actual)

May 20, 2024

Study Completion (Actual)

May 20, 2024

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (Actual)

December 29, 2017

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YJ-KY-2017-119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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