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NCT Number: NCT03385902

Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optimal start time

Other

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

late start time

Other

patients will start hemodialysis when their DIFE less than 30

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Dalian Medical University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ADIFE

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 29, 2017
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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