[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659262":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":50,"studyPopulation":43,"armGroups":51,"interventions":64,"overallOfficials":43,"centralContacts":74,"locations":80,"responsibleParty":112,"collaborators":116,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":43,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":43,"enrollmentInfo":129,"targetDuration":43,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":83,"whyStopped":43,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Regione del Veneto - AULSS n. 7 Pedemontana","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"All-cause mortality at 30 days","The primary endpoint of the study will be all-cause mortality at 30 days from hospital admission. Patient survival will be determined using one of the following methods: review of medical records, phone calls to the patient or their designated contact, or to the healthcare facility.","30 days from hospital admission",[14,18,22,25,28,31,35,39],{"measure":15,"description":16,"timeFrame":17},"Need for organ support","Proportion of participants who require initiation of mechanical ventilation and\u002For renal replacement therapy after study enrollment during the hospitalization period.","From enrollment through hospital discharge",{"measure":19,"description":20,"timeFrame":21},"Days free of organ support","defined as a patient alive and without assisted breathing, new invasive renal replacement therapy, or use of vasopressors (excluding vasopressor use before 48 hours). Each day a patient is alive and free of organ support counts as a day alive and free of organ support.","30 days after enrollment",{"measure":23,"description":24,"timeFrame":21},"Hours free of renal replacement therapy","the number of hours between enrollment and the start of renal replacement therapy. If a decision is made to initiate palliative care instead of renal replacement therapy, the hours counted will be from enrollment until the decision to start palliative care.",{"measure":26,"description":27,"timeFrame":17},"Initiation of vasopressor therapy","Proportion of participants requiring initiation of vasopressor therapy after study enrollment. The use of vasopressors will be recorded during the hospitalization period, including the type of vasopressor and the time of initiation.",{"measure":29,"description":30,"timeFrame":21},"Hours free of vasopressor","the number of hours between patient admission and start of vasopressor therapy. Patients requiring vasopressors who are instead started on palliative support therapy will be assigned \"hours free of vasopressor\" until the decision to start palliative care.",{"measure":32,"description":33,"timeFrame":34},"Change in SOFA score from baseline","Change in the Sequential Organ Failure Assessment (SOFA) score from the score recorded at study enrollment to subsequent daily assessments during hospitalization. The SOFA score will be calculated at enrollment and daily during the hospitalization period.","From enrollment through hospital discharge, assessed daily",{"measure":36,"description":37,"timeFrame":38},"Early mortality","mortality at 48 hours and 7 days","48 hours and 7 days",{"measure":40,"description":41,"timeFrame":42},"Length of stay","Number of days from study enrollment to hospital discharge. For participants who die before hospital discharge, the length of stay will be calculated from enrollment to the date of in-hospital death.","From enrollment through hospital discharge or in-hospital death",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":43,"primaryPurpose":47,"observationalModel":43,"timePerspective":43,"maskingInfo":48},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":49,"maskingDescription":43,"whoMasked":43},"NONE","This study is a prospective, multicenter, randomized, open-label, parallel-group interventional trial designed to compare two different strategies for the hemodynamic management of patients with sepsis admitted to medical wards. Participants will be randomly assigned in a 1:1 ratio to either a usual-care strategy or a treatment strategy guided by serial non-invasive hemodynamic monitoring.\n\nThe hemodynamic-guided strategy uses the Non-Invasive Cardiac System (NICaS; NI Medical, Petah-Tikva, Israel), an impedance-based non-invasive hemodynamic monitoring device. NICaS provides measurements of several macrohemodynamic parameters, including cardiac index, stroke volume index, cardiac power index, systemic vascular resistance index, and total body water. These measurements are used to characterize the patient's hemodynamic profile and to assess changes following fluid administration and during subsequent treatment.\n\nAfter enrollment, patients assigned to the hemodynamic-guided group undergo an initial non-invasive hemodynamic assessment followed by a standardized fluid challenge consisting of 10 mL\u002Fkg of crystalloid administered over 20 minutes. A subsequent NICaS assessment is performed to evaluate the hemodynamic response to fluid administration, including changes in stroke volume and other hemodynamic parameters. The resulting hemodynamic profile is used to support decisions regarding continuation of fluid therapy and\u002For initiation or adjustment of vasopressor therapy.\n\nDuring the first 12 hours after enrollment, serial non-invasive hemodynamic assessments are performed at 180-minute intervals. Based on the evolution of the measured parameters and the patient's clinical condition, fluid and\u002For vasopressor therapy may be modified with the aim of optimizing the patient's hemodynamic status. Treatment modifications, fluid administration, vasopressor therapy, and relevant clinical parameters are recorded prospectively.\n\nPatients randomized to the usual-care group are managed according to current clinical practice and applicable Surviving Sepsis Campaign recommendations. Fluid resuscitation and subsequent decisions regarding fluid administration and vasopressor therapy are made by the treating physician according to the patient's clinical condition and response to treatment.\n\nIn both groups, standardized clinical and laboratory reassessments are performed at predefined time points during the initial days after enrollment. These assessments include vital signs, fluid intake, urine output, blood gas analysis, laboratory parameters, and clinical assessment of organ function. Clinical severity scores are also recorded according to the study protocol. In the hemodynamic-guided group, the serial non-invasive hemodynamic measurements provide additional information to support treatment decisions.\n\nThe study will compare the clinical course of patients managed using usual care with that of patients managed using additional serial non-invasive hemodynamic information. In addition to the primary clinical outcome, the study will examine treatment requirements, organ support, fluid balance, vasopressor use, changes in organ dysfunction, and relationships between hemodynamic parameters and other clinical characteristics.\n\nParticipants will be followed during hospitalization and for 30 days after enrollment. Vital status and other relevant clinical information will be collected during follow-up.",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"A - Usual Care strategy","ACTIVE_COMPARATOR","Treatment per SSC Guidelines\n\nPatients receive fluid resuscitation with 30 ml\u002Fkg crystalloids over 3 hours. Fluid responsiveness is assessed by blood pressure increase and urine output.\n\nFluid responders (MAP \\>65 mmHg and urine output \\>1 ml\u002Fkg\u002Fh) continue maintenance fluids (1-2 ml\u002Fkg\u002Fh), adjusted by the physician.\n\nNon-fluid responders (MAP ≤65 mmHg or urine output \\\u003C1 ml\u002Fkg\u002Fh) start vasopressors to maintain MAP \\>65 mmHg, with dosage and fluid therapy managed by the physician.\n\nAll therapy changes are recorded.",[57],"Other: Treatment per SSC Guidelines",{"label":59,"type":60,"description":61,"interventionNames":62},"B - Strategy guided by non-invasive hemodynamic assessment","EXPERIMENTAL","For patients enrolled in arm B, a non-invasive hemodynamic assessment will be performed using the Non-Invasive Cardiac System (NICaS, NI Medical, Israel). The following parameters will be recorded: cardiac index (CI), stroke volume index (SV), cardiac power index (CPI), systemic vascular resistance index (SVRI), and total body water percentage (TBW).\n\nA fluid challenge will then be administered with 10 ml\u002Fkg of crystalloids over 20 minutes to assess fluid responsiveness. Hemodynamic response post-fluid challenge will be measured via NICaS. A SV increase \\>15% defines a \"fluid responder\" who will continue fluid therapy at 1-2 ml\u002Fkg\u002Fhr per guidelines. Those with less than 15% SV increase, decreased SVRI, or altered CPI are \"fluid non-responders\" and will receive vasopressor support, adjusted and recorded accordingly.\n\nHemodynamic evaluations via NICaS will be repeated every 180 minutes for the first 12 hours. Therapy will be adjusted to optimize CI, SV, CPI, SVRI.",[63],"Diagnostic Test: non-invasive hemodynamic assessment",[65,70],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":43},"DIAGNOSTIC_TEST","non-invasive hemodynamic assessment","Patients will be evaluated with non-invasive hemodynamic monitoring using NICaS, measuring cardiac index, stroke volume, cardiac power, vascular resistance, and total body water. A fluid challenge (10 ml\u002Fkg crystalloids in 20 minutes) will assess fluid responsiveness. Patients with \\>15% stroke volume increase (\"fluid responders\") will continue hydration therapy per guidelines. Those with ≤15% increase or altered hemodynamics (\"fluid non-responders\") will start vasopressor treatment. Hemodynamic monitoring repeats every 3 hours for 12 hours to guide therapy adjustments aiming to optimize key parameters (CI, SV, CPI, SVRI). All treatments, fluid balances, and vital signs are recorded systematically.",[59],{"type":6,"name":71,"description":72,"armGroupLabels":73,"otherNames":43},"Treatment per SSC Guidelines","Patients receive fluid resuscitation with 30 ml\u002Fkg crystalloids over 3 hours. Fluid responsiveness is assessed by blood pressure increase and urine output.\n\nFluid responders (MAP \\>65 mmHg and urine output \\>1 ml\u002Fkg\u002Fh) continue maintenance fluids (1-2 ml\u002Fkg\u002Fh), adjusted by the physician.\n\nNon-fluid responders (MAP ≤65 mmHg or urine output \\\u003C1 ml\u002Fkg\u002Fh) start vasopressors to maintain MAP \\>65 mmHg, with dosage and fluid therapy managed by the physician.\n\nAll therapy changes are recorded.",[53],[75],{"name":76,"role":77,"phone":78,"phoneExt":43,"email":79},"Massimo Marchetti, Dr.","CONTACT","+39 0445571608","massimo.marchetti@aulss7.veneto.it",[81,99],{"facility":82,"status":83,"city":84,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Policlinico Universitario di Pisa - UOC Medicina d'Urgenza","RECRUITING","Pisa","56124","Italy","IT",{"type":89,"coordinates":90},"Point",[91,92],10.4036,43.70853,{"lat":92,"lon":91},[95],{"name":96,"role":77,"phone":97,"phoneExt":43,"email":98},"Lorenzo Ghiadoni, Prof.","+39 050-996120","medurguni@ao-pisa.toscana.it",{"facility":100,"status":83,"city":101,"state":102,"zip":103,"country":86,"countryCode":87,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"AULSS 7 Pedemontana - UOC Medicina Generale PO Alto Vicentino - Santorso (VI)","Santorso","Vicenza","36014",{"type":89,"coordinates":105},[106,107],11.38785,45.73383,{"lat":107,"lon":106},[110],{"name":76,"role":77,"phone":111,"phoneExt":43,"email":79},"+39 0445 571608",{"type":113,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","Massimo Marchetti","Dr, Director of the General Medicine Department at Santorso Hospital (Alto Vicentino Hospital)",[117],{"name":118,"class":119},"University Hospital of Pisa","UNKNOWN","100659262","non-invasive-hemodynamic-optimization-of-sepsis-in-internal-medicine-a-randomized-study-comparing-therapy-guided-by-non-invasive-hemodynamic-indices-versus-standard-of-care-100659262",false,"NCT07863323","Non-invasive Hemodynamic Optimization of Sepsis in Internal Medicine: a Randomized Study Comparing Therapy Guided by Non-invasive Hemodynamic Indices Versus Standard of Care.","Ottimizzazione Emodinamica Non-invasiva Della Sepsi in Medicina Interna: Studio Randomizzato di Confronto Tra Terapia Diretta Agli Indici Emodinamici Non-invasivi Versus Standard di Cura. Codice Protocollo: EMODINAMICA_SEPSI","Inclusion Criteria:\n\n* Provision of specific informed consent;\n* Confirmed or suspected diagnosis of sepsis, defined according to the latest SSC guidelines as: \"the presence of a clear or suspected infection with life-threatening organ dysfunction caused by a dysregulated host response to infection indicated by a SOFA (Sequential Organ Failure Assessment) score ≥ 2\";\n* Patients of both sexes, aged 18 years or older;\n* Patients evaluated in the Emergency Department for suspected infection requiring hospital admission, at the General Medicine ward of Ospedale Alto Vicentino in Santorso (VI, Italy) or the Emergency Medicine ward of the Policlinico Universitario of Pisa (Italy).\n\nExclusion Criteria:\n\n* Stay in the Emergency Department of more than six hours, considered as the time between ED admission and ward admission;\n* Administration of more than 1000 cc of crystalloid therapy in the three hours prior to patient arrival in the ward;\n* Any admission from a facility or ward other than the Emergency Department;\n* Sepsis related to an ongoing hospital stay or any sepsis not fitting the definition of community-acquired infection;\n* Previous hospital admission within four weeks prior to ED access;\n* Sepsis related to trauma;\n* Presence of severe oncological disease with life expectancy less than 3 months at enrollment;\n* Active major bleeding;\n* Dialysis therapy;\n* Suspected or confirmed pregnancy;\n* Age under 18 years;\n* Patients who do not provide informed consent to the study.","ALL","18 Years",{"count":130,"type":131},430,"ESTIMATED","INTERVENTIONAL",[134],"NA","Background and Rationale Sepsis affects 20 to 30 million people globally each year, with an estimated 48.9 million cases in 2017. Despite medical advances, it still carries a high risk of death. Since sepsis progresses rapidly, early treatment is essential. This includes not only starting antibiotics quickly but also managing fluid levels effectively. Research suggests that in sepsis, fluid problems are often due to poor distribution in the body rather than an actual lack of fluids.\n\nCurrently, fluid and blood pressure management is often based only on monitoring arterial pressure, which may not provide a full picture of what's happening in the patient's circulatory system. More advanced indicators like Stroke Volume, Cardiac Output, and Peripheral Vascular Resistance can offer better guidance to optimize treatment and improve outcomes.\n\nNew non-invasive devices such as NICaS (Non-Invasive Cardiac System) make it easier and faster to monitor these values. NICaS uses electrical impedance technology and is approved by both the FDA and CE. It is easy to use, does not require specialized training, and allows for a more personalized and accurate treatment approach by tracking key heart and circulation parameters in real time.\n\nPrimary Objective\n\nThe main goal of this study is to compare two treatment strategies for patients with sepsis admitted to medical wards, and see which one leads to better survival:\n\n* Fluid and\u002For vasopressor therapy guided by non-invasive hemodynamic monitoring (using NICaS), based on values like Stroke Volume, Cardiac Power Index, and Peripheral Vascular Resistance.\n* Standard fluid therapy based on the international Surviving Sepsis Campaign (SSC) guidelines.\n\nSecondary Objectives\n\n* Use of vasopressors: Check which strategy leads to less frequent use of vasopressor drugs and shorter treatment duration with them.\n* Kidney function: See which method is linked to fewer cases needing dialysis or kidney support.\n* Timing of vasopressors: Understand if giving vasopressors earlier leads to better short- and mid-term outcomes, such as lower death rates after 30 days, fewer ICU admissions, and shorter hospital stays.\n* Albumin levels and circulation: Track how blood albumin levels change with circulation status, to see if there's a link with fluid leakage (capillary leak) and risk of death.\n* Fluid balance: Analyze how fluid gains and losses relate to changes in heart and circulation measurements.\n* Microcirculation: Test if adding signs of small vessel (microcirculation) issues to the main heart and blood flow indicators improves predictions of how patients will do.\n* Prediction scores: Investigate whether combining NICaS readings with common scoring systems like SOFA or APACHE helps doctors predict patient outcomes more accurately.\n* Time to stability: Compare how quickly patients in each treatment group recover to a stable condition. According to Rosenthal and Kavic's criteria, a patient is considered stable when: -Their illness is improving -There's low risk of getting worse again - Organ support is stable - There's little chance of new problems arising - There are no major complications.\n\nConclusion This study aims to evaluate whether a more personalized approach using real-time, non-invasive hemodynamic monitoring can lead to better outcomes in septic patients compared to standard care. If successful, this method could help reduce deaths, complications, and treatment costs in sepsis management.",[137,138],"Sepsis","Septic Shock",[140,141,142,143,144],"sepsis","septic shock","non invasive hemodynamics","fluid therapy","vasopressors","2026-10-01",{"date":147,"type":148},"2026-10-07","ACTUAL",{"date":150,"type":148},"2025-06-03",{"date":152,"type":131},"2026-11",{"name":5,"class":6},2]