Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation (NCT03385902) | Clinical Trial Compass
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 range18 Years – 75 Years
SexALL
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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
What they're measuring
1
all-cause mortality
Timeframe: from the date of enrollment until the end of study, assessed up to 3 years
2
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