Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-03 @ 12:35 AM
Study NCT ID:
NCT03385902
Status:
UNKNOWN
Last Update Posted:
2022-04-25
First Post:
2017-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-15', 'studyFirstSubmitDate': '2017-12-21', 'studyFirstSubmitQcDate': '2017-12-21', 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': 'from the date of enrollment until the end of study, assessed up to 3 years', 'description': 'proportion of patients who die from any cause'}, {'measure': 'cerebro-cardiovascular mortality', 'timeFrame': '3 years, from the date of enrollment until the end of study', 'description': 'proportion of patients who die from cerebro-cardiovascular disease'}], 'secondaryOutcomes': [{'measure': 'cerebro-cardiovascular events', 'timeFrame': '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', 'description': '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.'}, {'measure': 'hospitalization', 'timeFrame': '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', 'description': 'proportion of patients admitted to hospital'}, {'measure': 'Nutrition assessment', 'timeFrame': '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', 'description': "assess the patient's nutritional status by subjective global assessment (SGA) assessment and serum albumin level"}, {'measure': 'the change of quality of life', 'timeFrame': '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', 'description': "use short form-36 reported by the patients to assess the patient's quality of life"}, {'measure': 'Medical cost', 'timeFrame': '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', 'description': 'the cost by the patient, family and insurance during treatment'}, {'measure': 'Hemodialysis complications', 'timeFrame': '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', 'description': 'the proportion of patients who suffer from hemodialysis complications including blood assess revise, assess infection, severe fluid and electrolyte disorders'}, {'measure': 'cognitive dysfunction', 'timeFrame': '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', 'description': 'assess cognitive dysfunction by Montreal Cognitive Assessment (MoCA)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['end-stage renal disease', 'timing of dialysis initiation', 'hemodialysis', 'fuzzy mathematics', 'glomerular filtration rate'], 'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '20581422', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24508475', 'type': 'RESULT', '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 Study Investigators. Comparative effectiveness of early versus conventional timing of dialysis initiation in advanced CKD. Am J Kidney Dis. 2014 May;63(5):806-15. doi: 10.1053/j.ajkd.2013.12.010. Epub 2014 Feb 6.'}, {'pmid': '22465328', 'type': 'RESULT', '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.'}, {'pmid': '24492525', 'type': 'RESULT', '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 initiation of chronic dialysis. CMAJ. 2014 Feb 4;186(2):112-7. doi: 10.1503/cmaj.130363. No abstract available.'}, {'pmid': '24652801', 'type': 'RESULT', '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.'}, {'pmid': '20519231', 'type': 'RESULT', '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):2616-24. doi: 10.1093/ndt/gfq308. Epub 2010 Jun 2.'}, {'pmid': '31501092', 'type': 'DERIVED', 'citation': 'Chen J, Liu Y, Chen X, Sun X, Li W, Yang W, Li P, Sun X, Wang D, Jiang H, Shi W, Liu W, Fu P, Ding X, Chang M, Liu S, Yang X, Cao N, Chen M, Ni Z, Chen J, Sun S, Liang X, Wang H, He Y, Gao B, Wang J, Hao L, Liu J, Li S, He Q, Liu H, Yi N, Shao F, Jiao J, Ma Y, Yao L, Sun Y, Li D, Szczech L, Fang M, Odeh Z, Lin H. Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial. BMJ Open. 2019 Sep 8;9(9):e023162. doi: 10.1136/bmjopen-2018-023162.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have progressive chronic kidney disease with an eGFR less than 15 ml/min/1.73m2 and a DIFE between 30-35\n* Expected to commence maintenance hemodialysis as their renal replacement treatment\n* Agreeable to randomization\n\nExclusion Criteria:\n\n* Acute kidney injury (AKI) or AKI on chronic kidney disease (CKD)\n* With the primary disease of systemic lupus erythematosus (SLE) or systemic vasculitis\n* Have received or planning to receive a kidney transplant or peritoneal dialysis during the study\n* 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 )\n* Hepatocirrhosis\n* Positive test of Human Immunodeficiency Virus (HIV), the hepatitis B virus antigen (HBsAg) or anti-hepatitis C virus antibody (HCV Ab)\n* Acute infection within 1 month\n* Bad habit which is difficult to withdrawal such as alcohol abuse\n* Poor compliance and could not be treated according to the protocol\n* Being pregnant, nursing or having a plan for pregnancy\n* Life expectancy less than 1 year\n* The investigator confirm that should not enroll in the study with any other cases'}, 'identificationModule': {'nctId': 'NCT03385902', 'acronym': 'ADIFE', 'briefTitle': 'Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Dalian Medical University'}, 'officialTitle': 'Impact on Mortality of Timing of Dialysis Initiation in Patients With End-stage Renal Disease by a Novel Assessment Based on Fuzzy Mathematics', 'orgStudyIdInfo': {'id': 'YJ-KY-2017-119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'optimal start dialysis 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.', 'interventionNames': ['Other: optimal start time']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'late start dialysis 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.', 'interventionNames': ['Other: late start time']}], 'interventions': [{'name': 'optimal start time', 'type': 'OTHER', 'description': 'patients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30.', 'armGroupLabels': ['optimal start dialysis group']}, {'name': 'late start time', 'type': 'OTHER', 'description': 'patients will start hemodialysis when their DIFE less than 30', 'armGroupLabels': ['late start dialysis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116011', 'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'the First Affiliated Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}], 'overallOfficials': [{'name': 'Hongli Lin, MD， PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital of Dalian Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, {'name': 'Huashan Hospital', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'General hospital of benxi iron and steel co.', 'class': 'UNKNOWN'}, {'name': 'Dalian Municipal Central Hospital', 'class': 'OTHER'}, {'name': 'An Steel Group Hospital', 'class': 'UNKNOWN'}, {'name': 'The First Affiliated Hospital of the Fourth Military Medical University', 'class': 'OTHER'}, {'name': 'General Hospital of Mining Industry Group Fuxin', 'class': 'UNKNOWN'}, {'name': 'Affiliated Zhongshan Hospital of Dalian University', 'class': 'OTHER'}, {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, {'name': 'LanZhou University', 'class': 'OTHER'}, {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Xinjiang Medical University', 'class': 'OTHER'}, {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, {'name': 'Central Hospital Affiliated to Shenyang Medical Collage', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}