Clinical trial NCT03385902: Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation
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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: end-stage renal disease
timing of dialysis initiation
hemodialysis
fuzzy mathematics
glomerular filtration rate
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: Fudan University
name: RenJi Hospital
name: Guangdong Provincial People's Hospital
name: Beijing Friendship Hospital
name: Huashan Hospital
name: West China Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: First Affiliated Hospital of Harbin Medical University
name: The Second Affiliated Hospital of Harbin Medical University
name: General hospital of benxi iron and steel co.
name: Dalian Municipal Central Hospital
name: An Steel Group Hospital
name: The First Affiliated Hospital of the Fourth Military Medical University
name: General Hospital of Mining Industry Group Fuxin
name: The Affiliated Zhongshan Hospital of Dalian University
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: General Hospital of Ningxia Medical University
name: LanZhou University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Henan Provincial People's Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: First Hospital of China Medical University
name: Central hospital affiliated to shenyang medical college
First posted: 2017-12-29
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: all-cause mortality
timeFrame: from the date of enrollment until the end of study, assessed up to 3 years
measure: cerebro-cardiovascular mortality
timeFrame: 3 years, from the date of enrollment until the end of study
Secondary outcomes:
measure: cerebro-cardiovascular events
timeFrame: 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
measure: hospitalization
timeFrame: 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
measure: Nutrition assessment
timeFrame: 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
measure: the change of quality of life
timeFrame: 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
measure: Medical cost
timeFrame: 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
measure: Hemodialysis complications
timeFrame: 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
measure: cognitive dysfunction
timeFrame: 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
Other outcomes:
Locations:
city: Dalian
country: China
facility: the First Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Hongli Lin, MD， PhD
role: STUDY_DIRECTOR
References:
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