[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589776":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":32,"collaborators":7,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":7,"maxAge":7,"enrollmentInfo":45,"targetDuration":48,"studyType":49,"phases":7,"briefSummary":50,"conditions":51,"keywords":55,"overallStatus":60,"whyStopped":7,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"Hospital Ambroise Paré Paris","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","Echography","An exhaustive echography will be performed to determine fluid responsiveness (using a passive leg raising test and cardiac output measurement by left ventricular outflow tract velocity time integral)",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Adrien JOSEPH, MD, PhD","CONTACT","+33149094409","adrien.joseph@aphp.fr",[20],{"facility":21,"status":7,"city":22,"state":7,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":7},"Hôpital Ambroise Paré, Assistance Publique Hôpitaux de Paris,","Boulogne-Billancourt","92100","France","FR",{"type":27,"coordinates":28},"Point",[29,30],2.24128,48.83545,{"lat":30,"lon":29},{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Prof Antoine Vieillard-Baron","Professor","100589776","evolution-of-tissue-perfusion-and-venous-congestion-markers-in-fluid-responsive-septic-shock-patients-100589776",false,"NCT06958809","Evolution of Tissue Perfusion and Venous Congestion Markers in Fluid-Responsive Septic Shock Patients","Evolution of Tissue Perfusion and Venous Congestion Markers in Fluid-Responsive Septic Shock Patients: Evaluating the Benefit-Risk Balance of Fluid Resuscitation","FLUID-IMPACT","Inclusion Criteria:\n\n* Septic shock (sepsis-3 criteria)\n* Under mechanical ventilation\n* Central venous catheter in the superior vena cava territory and arterial catheter in place\n* Response to fluid resuscitation as per standard definition (i.e., an increase in cardiac output \\>10% assessed by subaortic velocity time integral \\[VTI\\] using echocardiography)\n\nExclusion Criteria:\n\n* Patient under 18 years of age\n* Lack of social security coverage \u002F adult under legal protection\n* Pregnant woman\n* Inability to obtain non-opposition consent","ALL",{"count":46,"type":47},200,"ESTIMATED","28 Days","OBSERVATIONAL","Septic shock remains a leading cause of mortality in intensive care, and while fluid resuscitation (FR) is a cornerstone of early management, its benefit-risk balance is highly variable. Excessive fluid administration can cause venous congestion and organ dysfunction, while insufficient resuscitation risks hypoperfusion. Current strategies often rely on fluid responsiveness (i.e., increased cardiac output after fluids), but this does not guarantee improved outcomes, particularly if congestion ensues.\n\nThis prospective, multicenter, observational study aims to assess the clinical impact of FR in septic shock patients who are fluid responsive. The primary objective is to evaluate changes in tissue perfusion and venous congestion markers following FR. Patients will be categorized into four response profiles based on the presence or absence of perfusion improvement and congestion worsening.\n\nSecondary objectives include exploring the prognostic implications of each profile (organ dysfunction, mortality), identifying pre-FR predictors of adverse responses, evaluating changes in congestion markers after passive leg raising (PLR), and performing phenotypic clustering and mediation analyses.\n\nEligible patients are adults with septic shock requiring vasopressors and mechanical ventilation, with confirmed fluid responsiveness via echocardiography. Each patient will undergo standardized pre- and post-FR assessments, including cardiac ultrasound, Doppler of hepatic\u002Fportal veins (VeXUS), CVP, perfusion markers, and blood gases.\n\nData on SOFA scores, organ support duration, and 28-day mortality will be collected. Approximately 170 patients will be enrolled across five ICUs experienced in advanced hemodynamic monitoring. Statistical analyses will include multivariate modeling, clustering, ROC curves, and mediation analyses.\n\nBy identifying phenotypes of fluid-responsive but fluid-intolerant patients, the study aims to refine fluid management strategies and improve outcomes through more personalized care in septic shock.",[52,53,54],"Septic Shock","Fluid Resuscitation","Congestion, Venous",[56,57,58,59],"septic shock","fluid resuscitation","venous congestion","tissue perfusion","NOT_YET_RECRUITING","2025-04-25",{"date":63,"type":64},"2025-05-06","ACTUAL",{"date":66,"type":47},"2026-02-01",{"date":68,"type":47},"2027-08-01",{"name":5,"class":6},1]