Chronic Kidney Disease
Conditions
Keywords
end-stage renal disease, timing of dialysis initiation, hemodialysis, fuzzy mathematics, glomerular filtration rate
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.
Interventions
OTHERoptimal start time
patients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30.
OTHERlate start time
patients will start hemodialysis when their DIFE less than 30
Sponsors
The First Affiliated Hospital of Dalian Medical University
Chinese PLA General Hospital
Fudan University
RenJi 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
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 Second Hospital
First Affiliated Hospital of Xinjiang Medical University
First Hospital of China Medical University
Central Hospital Affiliated to Shenyang Medical Collage
First Affiliated Hospital Xi'an Jiaotong University
Henan Provincial People's Hospital
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| all-cause mortality | from the date of enrollment until the end of study, assessed up to 3 years | proportion of patients who die from any cause |
| cerebro-cardiovascular mortality | 3 years, from the date of enrollment until the end of study | proportion of patients who die from cerebro-cardiovascular disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cerebro-cardiovascular events | 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. |
| hospitalization | 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 |
| Nutrition assessment | 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 |
| the change of 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 | use short form-36 reported by the patients to assess the patient's quality of life |
| Medical cost | 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 |
| Hemodialysis complications | 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 |
| cognitive dysfunction | 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) |
Countries
China
Contacts
STUDY_DIRECTORHongli Lin, MD， PhD
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed