[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100390191":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":58,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Incremental hemodialysis","EXPERIMENTAL","Procedure: Incremental hemodialysis. It consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session\u002Fweek, then the number of weekly sessions will be increased to two and later to three as per criteria for progression",[13],"Procedure: Incremental hemodialysis",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional hemodialysis","ACTIVE_COMPARATOR","Procedure: Conventional hemodialysis. It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group).",[19],"Procedure: Conventional hemodialysis",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","95 patients will start renal replacement therapy (RRT) with an incremental hemodialysis (once-weekly or twice-weekly) regimen.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"95 patients will start renal replacement therapy (RRT) with the standard (thrice-weekly) hemodialysis regimen.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Loreto Gesualdo, MD","CONTACT","+390805594041","loreto.gesualdo@uniba.it",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Domenico Roselli, MSc","+390805592778","domenico.roselli@policlinico.ba.it",[40],{"facility":41,"status":42,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Azienda Ospedaliero Universitaria Consorziale Policlinico","RECRUITING","Bari","70124","Italy","IT",{"type":48,"coordinates":49},"Point",[50,51],16.86982,41.12066,{"lat":51,"lon":50},[54,56],{"name":55,"role":32,"phone":33,"phoneExt":25,"email":34},"Loreto Gesualdo",{"name":57,"role":32,"phone":37,"phoneExt":25,"email":38},"Domenico Roselli",{"type":59,"investigatorFullName":31,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Full Professor of Nephrology University of Bari Aldo Moro - Head of the Nephrology, Dialysis and Transplantation Unit",[62],{"name":63,"class":6},"European Renal Association - European Dialysis and Transplant Association","100390191","randomized-clinical-trial-on-the-efficacy-and-safety-of-incremental-hemodialysis-real-life-100390191",false,"NCT04360694","RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis (REAL-LIFE)","RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis","Inclusion Criteria:\n\n* Adults aged \\> 18 years\n* Start of maintenance hemodialysis treatment due to advanced CKD stage 5D\n* Patients who are about to start HD or have already started HD within a period of ≤ 2 weeks\n* Glomerular filtration rate \\\u003C= 10 mL\u002Fmin\u002F1.73 m2, as estimated by means of CKD-EPI formula.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Acute kidney injury or acute on chronic kidney injury\n* eGFR higher than 10 mL\u002Fmin\u002F1.73 m2\n* UO \\\u003C 600 mL\u002Fday\n* Already treated with other replacement therapies (peritoneal dialysis or kidney transplant)\n* Unable or unwilling to give informed consent.\n* Unable to comply with trial procedures, e.g., collection of UO.\n* Likely survival prognosis or planned modality or centre transfer \\\u003C 6 months.\n* Patients who are in the waiting list for a living kidney transplant\n* Associated diseases: active neoplastic disease; refractory congestive heart failure (type IV NYHA, ejection fraction ≤ 30%) requiring high ultrafiltration volumes per session.","ALL","18 Years",{"count":74,"type":75},190,"ESTIMATED","INTERVENTIONAL",[78],"NA","Background: The thrice-weekly hemodialysis (HD) regimen is widely accepted as a standard prescription. The concept of incremental dialysis has been established as a possible alternative for patients with preserved diuresis and end-stage renal failure in need of HD. The main problems related to prescription of incremental HD are an arbitrary use of infrequent regimens and the lack of clear standards for incorporating residual kidney function (RKF) in the assessment of HD dose. Several models have been proposed for prescription of incremental dialysis. The latest, the variable target model (VTM), gives more clinical weight to the RKF and allows less frequent HD treatments at lower RKF. Despite increasing evidence derived from observational studies to support the use of incremental HD, RCTs are lacking and, therefore, urgently needed.\n\nMethods\u002FDesign:\n\nThe Department of Nephrology, Dialysis and Transplantation of the Azienda Ospedaliero Universitaria Consorziale Policlinico, Bari, Italy and the EUDIAL Working Group of the European Renal Association - European Dialysis Transplant Association (ERA-EDTA) are starting a randomized clinical trial (RCT) in incident HD patients, whose name is \"REAL LIFE\", by using the acronym of its whole definition: RandomizEd clinicAL triaL on the effIcacy and saFety of incremental haEmodialysis. REAL LIFE is a pragmatic, prospective, multicentre, open label RCT, investigator-initiated, comparing the intervention arm (incremental HD) with the control arm (standard 3HD\u002Fwk). The trial, originally conceived by experts at the Division of Nephrology of the Miulli General Hospital, Acquaviva delle Fonti, Italy, consists in starting the HD treatment adopting the new incremental approach guided by the VTM. The primary outcome is the survival of kidney function, with the event defined as urinary output (UO) ≤ 200 mL\u002Fday, confirmed by a further collection after 2 weeks to exclude temporary illness.\n\nDiscussion: REAL LIFE will enable the investigators to know with the highest level of scientific evidence the safety and efficacy of an incremental approach to the start of HD treatment.",[81],"End Stage Renal Disease on Dialysis","2024-06-11",{"date":84,"type":85},"2024-06-12","ACTUAL",{"date":87,"type":85},"2021-05-10",{"date":89,"type":75},"2026-12-31",{"name":5,"class":6},1]