Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation (ADIFE)

The First Affiliated Hospital of Dalian Medical University

Status: Unknown

Conditions: Chronic Kidney Disease

Treatments: Other: optimal start time; Other: late start time

Study type: Interventional

Funder types: Other

Identifiers

NCT03385902

YJ-KY-2017-119

Details and patient eligibility

About

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.

Full 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.

Enrollment: 388 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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388 participants in 2 patient groups

optimal start dialysis group

Experimental group

Description:

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.

Treatment:

Other: optimal start time

late start dialysis group

Active Comparator group

Description:

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.

Treatment:

Other: late start time