Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation

Chronic Kidney Disease Clinical Trial

— ADIFE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03385902
• Other study ID #: YJ-KY-2017-119
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 14, 2018
• Est. completion date: December 14, 2023

Study information

• Verified date: April 2022
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 388
• Est. completion date: December 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• optimal start time
patients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30.
• late start time
patients will start hemodialysis when their DIFE less than 30

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (26)

Lead Sponsor

Collaborator

The First Affiliated Hospital of Dalian Medical University

An Steel Group Hospital, Beijing Friendship Hospital, Central hospital affiliated to shenyang medical college, Chinese Academy of Medical Sciences, Fuwai Hospital, Chinese PLA General Hospital, Dalian Municipal Central Hospital, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital, Sun Yat-Sen University, First Hospital of China Medical University, Fudan University, General hospital of benxi iron and steel co., General Hospital of Mining Industry Group Fuxin, General Hospital of Ningxia Medical University, Guangdong Provincial People's Hospital, Henan Provincial People's Hospital, Huashan Hospital, LanZhou University, RenJi Hospital, The Affiliated Zhongshan Hospital of Dalian University, The First Affiliated Hospital of the Fourth Military Medical University, The Second Affiliated Hospital of Harbin Medical University, West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Cooper BA, Branley P, Bulfone L, Collins JF, Craig JC, Fraenkel MB, Harris A, Johnson DW, Kesselhut J, Li JJ, Luxton G, Pilmore A, Tiller DJ, Harris DC, Pollock CA; IDEAL Study. A randomized, controlled trial of early versus late initiation of dialysis. N Engl J Med. 2010 Aug 12;363(7):609-19. doi: 10.1056/NEJMoa1000552. Epub 2010 Jun 27. — View Citation

Crews DC, Scialla JJ, Boulware LE, Navaneethan SD, Nally JV Jr, Liu X, Arrigain S, Schold JD, Ephraim PL, Jolly SE, Sozio SM, Michels WM, Miskulin DC, Tangri N, Shafi T, Wu AW, Bandeen-Roche K; DEcIDE Network Patient Outcomes in End Stage Renal Disease St — View Citation

Hwang SJ, Yang WC, Lin MY, Mau LW, Chen HC; Taiwan Society of Nephrology. Impact of the clinical conditions at dialysis initiation on mortality in incident haemodialysis patients: a national cohort study in Taiwan. Nephrol Dial Transplant. 2010 Aug;25(8): — View Citation

Nesrallah GE, Mustafa RA, Clark WF, Bass A, Barnieh L, Hemmelgarn BR, Klarenbach S, Quinn RR, Hiremath S, Ravani P, Sood MM, Moist LM; Canadian Society of Nephrology. Canadian Society of Nephrology 2014 clinical practice guideline for timing the initiatio — View Citation

Sood MM, Komenda P, Rigatto C, Hiebert B, Tangri N. The association of eGFR reporting with the timing of dialysis initiation. J Am Soc Nephrol. 2014 Sep;25(9):2097-104. doi: 10.1681/ASN.2013090953. Epub 2014 Mar 20. — View Citation

Susantitaphong P, Altamimi S, Ashkar M, Balk EM, Stel VS, Wright S, Jaber BL. GFR at initiation of dialysis and mortality in CKD: a meta-analysis. Am J Kidney Dis. 2012 Jun;59(6):829-40. doi: 10.1053/j.ajkd.2012.01.015. Epub 2012 Apr 1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality	proportion of patients who die from any cause	from the date of enrollment until the end of study, assessed up to 3 years
Primary	cerebro-cardiovascular mortality	proportion of patients who die from cerebro-cardiovascular disease	3 years, from the date of enrollment until the end of study
Secondary	cerebro-cardiovascular events	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.	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
Secondary	hospitalization	proportion of patients admitted to hospital	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
Secondary	Nutrition assessment	assess the patient's nutritional status by subjective global assessment (SGA) assessment and serum albumin level	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
Secondary	the change of quality of life	use short form-36 reported by the patients to assess the patient's 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
Secondary	Medical cost	the cost by the patient, family and insurance during treatment	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
Secondary	Hemodialysis complications	the proportion of patients who suffer from hemodialysis complications including blood assess revise, assess infection, severe fluid and electrolyte disorders	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
Secondary	cognitive dysfunction	assess cognitive dysfunction by Montreal Cognitive Assessment (MoCA)	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