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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
388
patients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30.
patients will start hemodialysis when their DIFE less than 30
the First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
all-cause mortality
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
cerebro-cardiovascular mortality
proportion of patients who die from cerebro-cardiovascular disease
Time frame: 3 years, from the date of enrollment until the end of study
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.
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
hospitalization
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
Nutrition assessment
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
the change of quality of life
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
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Medical cost
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
Hemodialysis complications
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
cognitive dysfunction
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