[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616365":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":30,"responsibleParty":46,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":10,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":10,"enrollmentInfo":58,"targetDuration":61,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Izmir Katip Celebi University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Fluid Responders",null,"Defined as an increase in LVOT VTI-based Cardiac Output (CO) of ≥ 10% from baseline.",{"label":13,"type":10,"description":14,"interventionNames":10},"Fluid Non-Responders","Defined as an increase in LVOT VTI-based Cardiac Output (CO) of \\\u003C 10% from baseline.",[16],{"name":17,"affiliation":18,"role":19},"Murat Aksun","Izmir Katip Celebi University Atatürk Training and Research Hospital","PRINCIPAL_INVESTIGATOR",[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Murat Aksun, M.D.","CONTACT","+90 552 363 16 14","murataksun@yahoo.com",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Ahmet Salih Tüzen, M.D.","+90 535 391 55 77","astuzen@icloud.com",[31],{"facility":32,"status":10,"city":33,"state":10,"zip":10,"country":34,"countryCode":10,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Izmir Katip Celebi University Atatürk Training and Research Hospital İzmir, , Turkey","Izmir","Turkey (Türkiye)",{"type":36,"coordinates":37},"Point",[38,39],27.13838,38.41273,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":10,"email":45},"Elif Ersüs, M.D.","+90 537 944 60 59","elifersus@gmail.com",{"type":19,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ahmet Salih Tüzen, MD","Medical Doctor","100616365","comparison-of-ppv-and-lvot-vti-during-passive-leg-raising-to-predict-fluid-responsiveness-100616365",false,"NCT07304661","Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness","Comparison of Pulse Pressure Variation and LVOT VTI-Based Cardiac Output Changes During Passive Leg Raising Maneuver in Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Patients: A Prospective Observational Study","Inclusion Criteria:\n\n1. Adult patients aged ≥18 years\n2. Patients admitted to the intensive care unit receiving mechanical ventilation\n3. Presence of suspected intravascular fluid deficit (hypotension, negative fluid balance, or clinical signs of peripheral hypoperfusion)\n4. Patients in sinus rhythm\n5. Presence of invasive arterial blood pressure monitoring\n6. Adequate echocardiographic window allowing transthoracic echocardiographic measurement of LVOT VTI\n7. Patients ventilated with tidal volume ≥8 mL\u002Fkg (ideal body weight)\n8. Hemodynamically stable enough to allow measurement\n\nExclusion Criteria:\n\n1. Patients under 18 years of age\n2. Presence of atrial fibrillation or significant arrhythmias such as frequent ventricular or atrial ectopy\n3. Severe right ventricular dysfunction or significant tricuspid regurgitation\n4. Advanced aortic valve disease (severe stenosis or severe regurgitation)\n5. Patients with significant spontaneous breathing effort\n6. Patients receiving lung-protective low tidal volume ventilation strategy (\\\u003C8 mL\u002Fkg) due to ARDS\n7. Inadequate echocardiographic window for LVOT VTI assessment\n8. Severe hemodynamic instability during measurement (sudden vasopressor escalation or need for resuscitation)\n9. Patients who refuse to participate or from whom written informed consent cannot be obtained from themselves or a first-degree relative","ALL","18 Years",{"count":59,"type":60},48,"ESTIMATED","1 Day","OBSERVATIONAL","Hemodynamic instability remains one of the leading causes of morbidity and mortality among critically ill patients in intensive care units. One major contributor to this instability is intravascular fluid deficit. Although fluid administration is often preferred as an initial intervention, inaccurate estimation of fluid requirements carries significant risks. Inadequate resuscitation may lead to tissue hypoperfusion and organ dysfunction, whereas excessive fluid loading is associated with pulmonary edema, increased intra-abdominal pressure, multi-organ dysfunction, and increased mortality. Consequently, reliable prediction of fluid responsiveness is considered a critical determinant in modern intensive care management.\n\nThe limited reliability of static parameters in predicting fluid responsiveness and the fact that PPV retains its validity only under specific clinical conditions highlight the need for more effective methods. In recent years, hemodynamic changes assessed during the passive leg raising (PLR) maneuver have gained prominence; particularly, left ventricular outflow tract velocity time integral (LVOT VTI)-based cardiac output measurements have been identified as a strong parameter for predicting fluid responsiveness . Moreover, changes in pulse pressure variation (PPV) during PLR have also been reported as a potential predictor; however, the number of studies prospectively comparing PPV variation and LVOT VTI-based cardiac output change within the same patient population remains limited . Therefore, the proposed study aims to fill this gap in the literature and contribute to fluid management in the intensive care setting.\n\nThe aim of this study is to compare the performance of PPV variation and LVOT VTI-based cardiac output change after the PLR maneuver in predicting fluid responsiveness among mechanically ventilated critically ill patients, and to determine the diagnostic value of both methods. The findings of the present study are expected to support more reliable decision-making in fluid therapy and provide clinical evidence toward the individualization of fluid management in intensive care practice.",[65,66,67,68],"Hemodynamic Instability","Hypovolemia","Critical Illness","Pulse Pressure Variation",[70,71,68,72,73,74],"Fluid Responsiveness","Passive Leg Raising","LVOT VTI","Cardiac Output","Echocardiography","NOT_YET_RECRUITING","2025-12-13",{"date":78,"type":79},"2025-12-26","ACTUAL",{"date":81,"type":60},"2026-01-01",{"date":83,"type":60},"2027-06-01",{"name":5,"class":6},1]