CompletedNot Applicable

Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation

China388 participantsStarted 2018-04-14

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

all-cause mortality

Timeframe: from the date of enrollment until the end of study, assessed up to 3 years

cerebro-cardiovascular mortality

Timeframe: 3 years, from the date of enrollment until the end of study

Trial details

NCT IDNCT03385902

SponsorThe First Affiliated Hospital of Dalian Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-20

View on ClinicalTrials.gov More Chronic Kidney Disease trials