ADIFE: Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have progressive chronic kidney disease with an eGFR less than 15 ml/min/1.73m2 and a DIFE between 30-35
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Expected to commence maintenance hemodialysis as their renal replacement treatment
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Agreeable to randomization
Exclusion Criteria:
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Acute kidney injury (AKI) or AKI on chronic kidney disease (CKD)
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With the primary disease of systemic lupus erythematosus (SLE) or systemic vasculitis
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Have received or planning to receive a kidney transplant or peritoneal dialysis during the study
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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 )
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Hepatocirrhosis
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Positive test of Human Immunodeficiency Virus (HIV), the hepatitis B virus antigen (HBsAg) or anti-hepatitis C virus antibody (HCV Ab)
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Acute infection within 1 month
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Bad habit which is difficult to withdrawal such as alcohol abuse
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Poor compliance and could not be treated according to the protocol
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Being pregnant, nursing or having a plan for pregnancy
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Life expectancy less than 1 year
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The investigator confirm that should not enroll in the study with any other cases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | China | 116011 |
Sponsors and Collaborators
- The First Affiliated Hospital of Dalian Medical University
- Chinese PLA General Hospital
- Fudan University
- RenJi Hospital
- Guangdong Provincial People's 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
- The 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
- First Affiliated Hospital Xi'an Jiaotong University
- Henan Provincial People's Hospital
- First Affiliated Hospital of Xinjiang Medical University
- First Hospital of China Medical University
- Central hospital affiliated to shenyang medical college
Investigators
- Study Director: Hongli Lin, MD， PhD, The First Affiliated Hospital of Dalian Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
- YJ-KY-2017-119