[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647159":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":57,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":26,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Universidad Autonoma de Nuevo Leon","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standar Group","ACTIVE_COMPARATOR","Receives a standard fluid removal rate of 10 mL\u002Fkg\u002Fh.",[13],"Procedure: Standard fluid removal",{"label":15,"type":16,"description":17,"interventionNames":18},"High-Rate Group","EXPERIMENTAL","Receives a higher fluid removal rate of over 13 mL\u002Fkg\u002Fh (with a safety up to 15 mL\u002Fkg\u002Fh).",[19],"Procedure: High-rate ultrafiltration",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","High-rate ultrafiltration","This intervention consists of fluid removal (ultrafiltration) during the first in-hospital hemodialysis session of a patient with advanced Chronic Kidney Disease, utilizing a high rate greater than 13 mL\u002Fkg\u002Fh (with a strict safety limit established between \\>13 and up to 15 mL\u002Fkg\u002Fh).The differentiating value of this protocol lies in the fact that it challenges traditional medical dogma by combining an aggressive rate with advanced multiparametric ultrasound tools, something that had not been formally structured in previous clinical trials.",[15],null,{"type":22,"name":28,"description":11,"armGroupLabels":29,"otherNames":26},"Standard fluid removal",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Edgar Adrián Montemayor, Nephrology Fellow","CONTACT","+52 8180911271","edgar.montemayorga@uanl.edu.mx",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Hospital Universitario \"Dr. José E. González\"","RECRUITING","Monterrey","Nuevo León","64460","Mexico","MX",{"type":46,"coordinates":47},"Point",[48,49],-100.31721,25.68435,{"lat":49,"lon":48},[52],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Edgar Adrián Montemayor Garza","Nephrology Fellow",[58],{"name":59,"class":6},"Hospital Universitario Dr. Jose E. Gonzalez","100647159","the-filtrate-trial-high-rate-ultrafiltration-for-intravascular-congestion-100647159",false,"NCT07705269","The FILTRATE Trial: High-Rate Ultrafiltration for Intravascular Congestion","FluId removaL With a High Rate ulTRAfiltration Protocol in paTiEnts With Intravascular Congestion: the FILTRATE Trial","FILTRATE","Inclusion Criteria:\n\n* Adults over 18 years old with End-Stage Renal Disease on hemodialysis for at least 3 months.\n* Admitted to the hospital requiring mechanical fluid removal for acute fluid overload (first in-hospital session).\n* Clear ultrasound evidence of severe intravascular congestion (such as diffuse B-lines in the lungs or altered VExUS vascular flow patterns).\n* Hemodynamically stable with a baseline blood pressure of at least 120\u002F80 mmHg.\n\nExclusion Criteria:\n\n* Baseline low blood pressure (\\\u003C100\u002F60 mmHg) or active shock (cardiogenic, septic, or distributive).\n* Acute coronary syndrome (heart attack), severe heart valve disease, or severe fluid around the heart.\n* Known chronic lung disease.\n* Pregnancy.","ALL","18 Years",{"count":71,"type":72},70,"ESTIMATED","INTERVENTIONAL",[75],"NA","The purpose of this study is to evaluate whether a personalized, high-rate fluid removal strategy guided by ultrasound is as safe and effective as the standard fluid removal rate for patients with advanced kidney disease who are hospitalized due to severe fluid overload (congestion).\n\nWhen patients with End-Stage Renal Disease (ESRD) on chronic hemodialysis are admitted to the hospital with excess fluid, doctors often need to remove this fluid quickly to relieve symptoms like severe shortness of breath. However, traditional guidelines recommend conservative fluid removal rates-called ultrafiltration (UF) rates-between 10 and 13 mL\u002Fkg\u002Fh to prevent sudden drops in blood pressure (intradialytic hypotension). Despite these guidelines, doctors in real-world hospital settings frequently use higher rates to provide urgent relief, though this practice lacks strong scientific backing.\n\nThis study utilizes advanced bedside ultrasound protocols (such as lung ultrasound and VExUS) to objectively measure the amount of fluid congestion inside the patient's blood vessels. The researchers hypothesize that patients with high ultrasound markers of congestion can safely tolerate higher fluid removal rates because their blood vessels are overfilled, meaning fluid can be pulled out faster without causing blood pressure drops.\n\nParticipants will be randomly assigned to one of two groups during their first in-hospital hemodyalisis session:\n\n* Standard Group: Receives a standard fluid removal rate of 10 mL\u002Fkg\u002Fh.\n* High-Rate Group: Receives a higher fluid removal rate of over 13 mL\u002Fkg\u002Fh (with a safety ceiling up to 15 mL\u002Fkg\u002Fh).\n\nThe study will compare the two groups over the first 24 hours to monitor blood pressure stability (safety) and check for improvements in ultrasound congestion scores, shortness of breath, and the need for supplemental oxygen (effectiveness).",[78,79,80,81],"End Stage Chronic Renal Failure","Congestive Heart Failure (CHF)","Intravascular Congestion","Fluid Overload","2026-07-12",{"date":84,"type":85},"2026-07-15","ACTUAL",{"date":87,"type":85},"2026-06-04",{"date":89,"type":72},"2027-10",{"name":5,"class":6},1]