Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation (ADIFE)
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ClinicalTrials.gov Identifier: NCT03385902 |
Recruitment Status :
Active, not recruiting
First Posted : December 29, 2017
Last Update Posted : April 25, 2022
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Condition or disease | Intervention/treatment | Phase |
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Chronic Kidney Disease | Other: optimal start time Other: late start time | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 388 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Impact on Mortality of Timing of Dialysis Initiation in Patients With End-stage Renal Disease by a Novel Assessment Based on Fuzzy Mathematics |
Actual Study Start Date : | April 14, 2018 |
Estimated Primary Completion Date : | August 14, 2023 |
Estimated Study Completion Date : | December 14, 2023 |

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.
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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.
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Other: late start time
patients will start hemodialysis when their DIFE less than 30 |
- all-cause mortality [ Time Frame: 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 [ Time Frame: 3 years, from the date of enrollment until the end of study ]proportion of patients who die from cerebro-cardiovascular disease
- cerebro-cardiovascular events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385902
China, Liaoning | |
the First Affiliated Hospital of Dalian Medical University | |
Dalian, Liaoning, China, 116011 |
Study Director: | Hongli Lin, MD, PhD | The First Affiliated Hospital of Dalian Medical University |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | The First Affiliated Hospital of Dalian Medical University |
ClinicalTrials.gov Identifier: | NCT03385902 |
Other Study ID Numbers: |
YJ-KY-2017-119 |
First Posted: | December 29, 2017 Key Record Dates |
Last Update Posted: | April 25, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
end-stage renal disease timing of dialysis initiation hemodialysis fuzzy mathematics glomerular filtration rate |
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |