Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-25 @ 5:00 PM
Study NCT ID:
NCT00413803
Status:
COMPLETED
Last Update Posted:
2009-08-04
First Post:
2006-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-10-30', 'releaseDate': '2015-10-04'}], 'estimatedResultsFirstSubmitDate': '2015-10-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 410}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-03', 'studyFirstSubmitDate': '2006-12-19', 'studyFirstSubmitQcDate': '2006-12-19', 'lastUpdatePostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total mortality', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'cardiovascular mortality', 'timeFrame': 'one year'}, {'measure': 'changes in health-related quality of life, depression burden, cognitive function', 'timeFrame': 'one year'}, {'measure': 'required medications', 'timeFrame': 'one year'}, {'measure': 'total cost', 'timeFrame': 'one year'}, {'measure': 'changes in blood pressure, left ventricular geometry, coronary artery calcification, arterial stiffness,upper mid-arm circumference,hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin', 'timeFrame': 'one year'}, {'measure': 'hospitalization rate', 'timeFrame': 'one year'}, {'measure': 'Vascular access patency', 'timeFrame': 'one year'}, {'measure': 'post-dialysis body weight and total body water', 'timeFrame': 'one year'}, {'measure': 'arrythmia episodes determined by Holter-ECG', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Nocturnal dialysis', 'Cardiovascular disease', 'Quality of Life', 'left ventricular hypertrophy'], 'conditions': ['End-Stage Renal Disease', 'Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '22172590', 'type': 'DERIVED', 'citation': 'Demirci MS, Celik G, Ozkahya M, Tumuklu M, Toz H, Asci G, Duman S, Basci A, Kircelli F, Ozdogan O, Demirci C, Can L, Isik IO, Ok E; Long Dialysis Group. Effects of thrice weekly nocturnal hemodialysis on arterial stiffness. Atherosclerosis. 2012 Feb;220(2):477-85. doi: 10.1016/j.atherosclerosis.2011.11.015. Epub 2011 Nov 19.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that an increase in the duration of dialysis session in thrice weekly center hemodialysis may provide better outcome, less morbidity, higher quality of life, lesser requirement of medications, and lower total cost.', 'detailedDescription': 'The proposed prospective and controlled clinical trial aims to compare 4-hour and 8-hour dialysis sessions in thrice weekly center HD regarding mortality, hospitalization rate, several clinical and laboratory parameters, and total cost. Four hundred and ten HD patients will be taken into the study. The study will last for 12 months. The patients will be placed in two groups:\n\n1. Four-hour dialysis session, blood flow rate 300-400 ml/min\n2. Eight-hours dialysis session, blood flow rate 200-250 ml/min\n\nSample size is estimated with following hypotheses: twelve months duration of follow-up; twelve months survival of the control group 85%; a bilateral alpha risk equal to 5%; an expectation that 12-months survival to be 95% by 8-hours dialysis; a 85% power to detect the decrease in annual mortality by 8-hours dialysis comparing to 4-hours dialysis; a 10% of dropout rate. The required sample is total 410 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18-years\n* On maintenance bicarbonate HD scheduled thrice weekly 12 hours/week; achieved mean single pool Kt/V above 1.2\n* Willingness to participate in the study with a written informed consent\n\nExclusion Criteria:\n\n* To be scheduled for living donor renal transplantation\n* To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease\n* Pregnancy or lactating\n* Current requirement for HD more than three times per week due to medical comorbidity\n* GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours\n* Use of temporary catheter\n* Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial\n* Mental incompetence'}, 'identificationModule': {'nctId': 'NCT00413803', 'briefTitle': 'Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis: Long Dialysis Study', 'orgStudyIdInfo': {'id': '06-5.1/8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Four-hour dialysis session, blood flow rate 300-400 ml/min', 'interventionNames': ['Procedure: 4-hour thrice weekly in center hemodialysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Eight-hours dialysis session, blood flow rate 200-250 ml/min', 'interventionNames': ['Procedure: 8-hour thrice weekly in center hemodialysis']}], 'interventions': [{'name': '4-hour thrice weekly in center hemodialysis', 'type': 'PROCEDURE', 'description': 'conventional hemodialysis', 'armGroupLabels': ['1']}, {'name': '8-hour thrice weekly in center hemodialysis', 'type': 'PROCEDURE', 'description': 'long dialysis', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01100', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'FMC Turkey Clinics', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University School of Medicine Nephrology Department', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Ercan Ok, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fresenius Medical Care North America', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Fresenius Medical Care', 'oldOrganization': 'Fresenius Medical Care'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-10-04', 'type': 'RELEASE'}, {'date': '2015-10-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ercan OK, professor, Ege University'}}}}