[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642154":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":58,"studyPopulation":59,"armGroups":60,"interventions":54,"overallOfficials":64,"centralContacts":69,"locations":77,"responsibleParty":233,"collaborators":54,"id":236,"slug":237,"hasResults":238,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":238,"sex":243,"minAge":244,"maxAge":54,"enrollmentInfo":245,"targetDuration":54,"studyType":248,"phases":54,"briefSummary":249,"conditions":250,"keywords":256,"overallStatus":137,"whyStopped":54,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":273},{"fullName":5,"class":6},"Hospital Las Higueras","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"Development of Ultrafiltration Intolerance","Proportion of patients who develop ultrafiltration intolerance according to the protocol-defined composite criteria, including hypotension, increased vasopressor requirements, worsening peripheral perfusion, tissue hypoperfusion, or reduction\u002Finterruption of ultrafiltration due to instability.","From UFNET initiation (T0) to 24 hours after initiation of net ultrafiltration",[14,18,21,25,28,31,35,38,42,46,50],{"measure":15,"description":16,"timeFrame":17},"Incidence of Ultrafiltration Intolerance","Percentage of participants who develop ultrafiltration intolerance during the observation period.","From UFNET initiation (T0) to 24 hours.",{"measure":19,"description":20,"timeFrame":17},"Net Ultrafiltration Rate (mL\u002Fkg\u002Fh)","Prescribed and achieved net ultrafiltration rate during continuous renal replacement therapy.",{"measure":22,"description":23,"timeFrame":24},"Time to First Ultrafiltration Intolerance Event (hours)","Time from UFNET initiation to the first occurrence of ultrafiltration intolerance.","From UFNET initiation to 24 hours.",{"measure":26,"description":27,"timeFrame":24},"Severity Category of Ultrafiltration Intolerance","Proportion of participants classified as having mild, moderate, or severe ultrafiltration intolerance according to protocol-defined criteria. Higher categories indicate greater severity of intolerance.",{"measure":29,"description":30,"timeFrame":24},"Agreement Between Hypotension-Based and Hypoperfusion-Based Definitions of Ultrafiltration Intolerance","Agreement between intolerance defined by hypotension criteria and intolerance defined by tissue hypoperfusion criteria, assessed using Cohen's kappa coefficient.",{"measure":32,"description":33,"timeFrame":34},"Cumulative Fluid Balance (mL)","Cumulative fluid balance achieved during the first 24 hours following UFNET initiation.","24 hours after UFNET initiation",{"measure":36,"description":37,"timeFrame":34},"Achieved Net Ultrafiltration Volume (mL)","Total net ultrafiltration volume achieved during the observation period.",{"measure":39,"description":40,"timeFrame":41},"Proportion of Participants Achieving Renal Recovery","Percentage of participants who recover kidney function sufficiently to discontinue kidney replacement therapy according to the treating clinical team.","Up to 90 days after UFNET initiation",{"measure":43,"description":44,"timeFrame":45},"Ventilator-Free Days","Number of days alive and free from invasive mechanical ventilation.","Up to 28 days after UFNET initiation",{"measure":47,"description":48,"timeFrame":49},"Intensive Care Unit Mortality","Percentage of participants who die during intensive care unit admission.","From UFNET initiation up to 90 days or ICU discharge, whichever occurs first",{"measure":51,"description":52,"timeFrame":53},"Hospital Mortality","Percentage of participants who die during hospital admission.","From UFNET initiation until hospital discharge, assessed up to 180 days",null,{"allocation":54,"interventionModel":54,"interventionModelDescription":54,"primaryPurpose":54,"observationalModel":56,"timePerspective":57,"maskingInfo":54},"CASE_CONTROL","PROSPECTIVE","Fluid overload is a frequent and clinically relevant complication in critically ill patients with acute kidney injury (AKI). In this setting, continuous renal replacement therapy (CRRT) is frequently used not only for solute control but also as a strategy for controlled fluid removal through net ultrafiltration (UFNET). Although UFNET is central to de-resuscitation, the individual tolerance to fluid removal is highly variable and is not fully captured by blood pressure monitoring alone.\n\nThe concept of ultrafiltration intolerance remains poorly standardized. In clinical practice, intolerance is often recognized only after overt hemodynamic instability occurs, such as hypotension, escalation of vasoactive support, or interruption of fluid removal. However, reductions in cardiac output, impaired tissue perfusion, or worsening venous congestion may precede overt hypotension. Therefore, a multiparametric assessment may allow earlier identification of patients at risk.\n\nThis is a prospective, observational, analytical study in critically ill adult patients with AKI receiving CRRT with prescribed UFNET. The study does not assign or modify therapeutic interventions. CRRT modality, anticoagulation strategy, UFNET prescription, vasopressor management, fluid administration, and all other clinical decisions will remain under the responsibility of the treating clinical team according to routine care.\n\nThe study will characterize the physiological response to UFNET using a structured multiparametric monitoring approach. Recorded domains will include conventional macrohemodynamic variables, vasoactive support, selected advanced hemodynamic variables when available, focused cardiac ultrasound, venous congestion assessment, peripheral perfusion parameters, fluid balance variables, and selected biochemical markers. Functional hemodynamic maneuvers may be performed when feasible and clinically safe.\n\nData will be collected prospectively using a standardized case report form. Variables will be recorded at predefined time points before and during the early phase of UFNET, with additional off-schedule recordings if clinical signs compatible with intolerance occur. Source data will be obtained from the electronic or paper medical record, bedside monitoring systems, CRRT prescription and treatment records, laboratory results, and ultrasound assessments performed as part of clinical evaluation.\n\nA data dictionary will define each variable, including its source, units, coding, and expected physiological range when applicable. Data quality procedures will include review of completeness, range checks, consistency checks between related variables, and verification of clinically implausible values against source records. The research team will periodically review entered data to identify missing, inconsistent, or out-of-range values.\n\nData will be anonymized before analysis. No directly identifiable patient information will be stored in the final analytical database. Access to the study database will be restricted to authorized study investigators. Data will be stored using password-protected institutional or investigator-controlled systems according to local confidentiality and ethical requirements.\n\nThe planned sample size is 128 participants, including an estimated analytical sample of 116 participants and an approximate 10% over-recruitment to account for incomplete data, missing assessments, or inability to definitively adjudicate the outcome. The sample size was based on an analytical case-control approach aimed at identifying factors associated with ultrafiltration intolerance.\n\nMissing data will be evaluated before statistical analysis. Variables with substantial missingness may be excluded from inferential analyses. For variables with acceptable levels of missingness, available-case analysis will be performed. The extent and pattern of missing data will be reported.\n\nStatistical analysis will include descriptive statistics, comparison between patients who develop ultrafiltration intolerance and those who do not, and exploratory modeling to identify factors independently associated with intolerance. Continuous variables will be summarized using median and interquartile range or mean and standard deviation, as appropriate. Categorical variables will be summarized as frequencies and percentages. Group comparisons will be performed using appropriate parametric or non-parametric tests according to data distribution. Multivariable logistic regression may be used to explore independent predictors, with covariate selection based on clinical relevance and number of events.\n\nThe overall objective of this study is to improve the characterization of ultrafiltration intolerance during CRRT and to generate evidence that may support individualized, physiology-guided fluid removal strategies in critically ill patients with AKI.","Adult critically ill patients admitted to participating intensive care units with acute kidney injury requiring continuous renal replacement therapy and prescribed net ultrafiltration as part of routine clinical care.",[61],{"label":62,"type":54,"description":63,"interventionNames":54},"AKI Patients Receiving CRRT With Net Ultrafiltration","Adult critically ill patients with acute kidney injury receiving continuous renal replacement therapy with prescribed net ultrafiltration. Participants will be prospectively evaluated using a multiparametric monitoring strategy including clinical, hemodynamic, ultrasound, perfusion, and biochemical assessments. Patients will subsequently be classified according to the development or absence of ultrafiltration intolerance during the observation period.",[65],{"name":66,"affiliation":67,"role":68},"Gonzalo Ramírez-Guerrero, MD","Hospital Las Higueras de Talcahuano","PRINCIPAL_INVESTIGATOR",[70,74],{"name":66,"role":71,"phone":72,"phoneExt":54,"email":73},"CONTACT","+56981746173","ramirezguerrero.g@gmail.com",{"name":75,"role":71,"phone":54,"phoneExt":54,"email":76},"Cristian Pedreros-Rosales, MD","cpedreros@me.com",[78,95,110,123,136,154,169,184,199,218],{"facility":79,"status":80,"city":81,"state":54,"zip":54,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Hospital Cárdio Pulmonar","NOT_YET_RECRUITING","Salvador","Brazil","BR",{"type":85,"coordinates":86},"Point",[87,88],-38.49096,-12.97563,{"lat":88,"lon":87},[91],{"name":92,"role":71,"phone":93,"phoneExt":54,"email":94},"Maria Gabriela Guimarães, MD","+5571982121211","Gabrielaguimar@hotmail.com",{"facility":96,"status":80,"city":97,"state":54,"zip":54,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Hospital Clínico Regional de Concepción","Concepción","Chile","CL",{"type":85,"coordinates":101},[102,103],-73.04977,-36.82699,{"lat":103,"lon":102},[106],{"name":107,"role":71,"phone":108,"phoneExt":54,"email":109},"Marcos Hernandez, MD","+56976685604","md.hernandezdiaz@gmail.com",{"facility":111,"status":80,"city":112,"state":54,"zip":54,"country":98,"countryCode":99,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Complejo Asistencial Dr. Victor Ríos Ruiz","Los Ángeles",{"type":85,"coordinates":114},[115,116],-72.35366,-37.46973,{"lat":116,"lon":115},[119],{"name":120,"role":71,"phone":121,"phoneExt":54,"email":122},"Carolina Carrasco, MD","+56975583888","carolina.carrascoa@gmail.com",{"facility":124,"status":80,"city":125,"state":54,"zip":54,"country":98,"countryCode":99,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Hospital Clínico Dra. Eloísa Díaz Insunza de La Florida","Santiago",{"type":85,"coordinates":127},[128,129],-70.64827,-33.45694,{"lat":129,"lon":128},[132],{"name":133,"role":71,"phone":134,"phoneExt":54,"email":135},"Eduardo Chinchón, MD","+56994514773","doctorchinchon@gmail.com",{"facility":67,"status":137,"city":138,"state":54,"zip":54,"country":98,"countryCode":99,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"RECRUITING","Talcahuano",{"type":85,"coordinates":140},[141,142],-73.11684,-36.72494,{"lat":142,"lon":141},[145,146,147,150,152],{"name":66,"role":71,"phone":72,"phoneExt":54,"email":73},{"name":75,"role":71,"phone":54,"phoneExt":54,"email":76},{"name":148,"role":149,"phone":54,"phoneExt":54,"email":54},"Rodrigo Ulloa, MD","SUB_INVESTIGATOR",{"name":151,"role":149,"phone":54,"phoneExt":54,"email":54},"Jonathan Alarcón, MD",{"name":153,"role":149,"phone":54,"phoneExt":54,"email":54},"Ricardo Ferrada, MD",{"facility":155,"status":137,"city":156,"state":54,"zip":54,"country":157,"countryCode":158,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Hospital Universitario San José de Popayán","Popayán","Colombia","CO",{"type":85,"coordinates":160},[161,162],-76.61316,2.43823,{"lat":162,"lon":161},[165],{"name":166,"role":71,"phone":167,"phoneExt":54,"email":168},"David Ballesteros, MD","+573105542506","david.ballesteros.c@gmail.com",{"facility":170,"status":80,"city":171,"state":54,"zip":54,"country":172,"countryCode":173,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Hospital General Enrique Garces","Quito","Ecuador","EC",{"type":85,"coordinates":175},[176,177],-78.52495,-0.22985,{"lat":177,"lon":176},[180],{"name":181,"role":71,"phone":182,"phoneExt":54,"email":183},"Darío Jiménez, MD","+593992773176","dxjimenezmd@gmail.com",{"facility":185,"status":80,"city":186,"state":54,"zip":54,"country":187,"countryCode":188,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Ospedale San Bortolo","Vicenza","Italy","IT",{"type":85,"coordinates":190},[191,192],11.5475,45.54672,{"lat":192,"lon":191},[195],{"name":196,"role":71,"phone":197,"phoneExt":54,"email":198},"Matteo Marcello, MD","+393925743247","matteo.marcello92@gmail.com",{"facility":200,"status":137,"city":201,"state":54,"zip":54,"country":202,"countryCode":203,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Hospital General de Mexico","Mexico City","Mexico","MX",{"type":85,"coordinates":205},[206,207],-99.12766,19.42847,{"lat":207,"lon":206},[210,214],{"name":211,"role":71,"phone":212,"phoneExt":54,"email":213},"Pablo Galindo, MD","+525551564682","drgalindo@nefrologoscdmx.com",{"name":215,"role":71,"phone":216,"phoneExt":54,"email":217},"Sandra Ávila, MD","+524778808890","sandrapav@hotmail.es",{"facility":219,"status":80,"city":220,"state":54,"zip":54,"country":221,"countryCode":222,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Hospital Nacional Cayetano Heredia","Lima","Peru","PE",{"type":85,"coordinates":224},[225,226],-77.02824,-12.04318,{"lat":226,"lon":225},[229],{"name":230,"role":71,"phone":231,"phoneExt":54,"email":232},"Raúl Valenzuela, MD","+51999308278","raul.valenzuela.cordova@gmail.com",{"type":68,"investigatorFullName":234,"investigatorTitle":235,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"Gonzalo Ramirez Guerrero","Principal Investigator - Nephrologist","100642154","volume-removal-intolerance-during-net-ultrafiltration-in-acute-kidney-injury-patients-100642154",false,"NCT07643597","Volume Removal Intolerance During Net Ultrafiltration in Acute Kidney Injury Patients","VINKO","Inclusion Criteria:\n\n* Age ≥18 years\n* Admission to an Intensive Care Unit\n* Acute kidney injury according to KDIGO criteria\n* Prescription of continuous renal replacement therapy (CRRT) with net ultrafiltration\n* Clinical stability considered sufficient to initiate net ultrafiltration according to the treating clinical team\n\nExclusion Criteria:\n\n* Chronic kidney replacement therapy prior to ICU admission\n* Pregnancy\n* Limitation of therapeutic effort or goals-of-care decisions at admission or during the observation period\n* Inability to perform hemodynamic or perfusion assessment\n* Extracorporeal membrane oxygenation (ECMO)\n* Refusal to participate in the study","ALL","18 Years",{"count":246,"type":247},128,"ESTIMATED","OBSERVATIONAL","Acute kidney injury (AKI) is common in critically ill patients and is frequently associated with fluid overload, which can worsen clinical outcomes. Continuous renal replacement therapy (CRRT) allows fluid removal through net ultrafiltration (UFNET), but some patients develop hemodynamic instability or signs of poor tissue perfusion during this process.\n\nThe purpose of this prospective observational study is to evaluate tolerance to net ultrafiltration in critically ill patients with AKI receiving CRRT. The study will assess clinical, hemodynamic, ultrasound, perfusion, and biochemical parameters before and during fluid removal to identify factors associated with ultrafiltration intolerance.\n\nThe investigators hypothesize that alterations in hemodynamic, perfusion, and congestion-related parameters can identify patients at increased risk of ultrafiltration intolerance before the development of overt hypotension. The results may help improve individualized fluid removal strategies and optimize the safety of CRRT in critically ill patients.",[251,252,253,254,255],"Acute Kidney Injury","Fluid Overload","Fluid Overload in Dialysis Patients","Critical Illness","Renal Replacement Therapy for Acute Kidney Injury in ICU",[257,258,259,260,261,252,262,263],"Net Ultrafiltration","Continuous Renal Replacement Therapy","Fluid Removal","Ultrafiltration Intolerance","Tissue Hypoperfusion","VExUS","Point-of-Care Ultrasound","2026-07-05",{"date":266,"type":267},"2026-07-08","ACTUAL",{"date":269,"type":267},"2026-07-06",{"date":271,"type":247},"2027-12-01",{"name":5,"class":6},10]