[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465104":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":39,"responsibleParty":57,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":18,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Goal-Directed Therapy Group","EXPERIMENTAL","Patients allocated to the Goal-Directed Therapy group will be monitored by the ClearSight™ System (Edwards Life Sciences, Irvine, CA, USA) in the first 24 hours after randomization, where the parameters Cardiac Index (CI), Stroke Volume (SV), Systolic Blood Pressure (SBP) and Mean Arterial Pressure (MAP) will be acquired continuously.",[13],"Device: Goal-Directed Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Therapy Group","NO_INTERVENTION","Patients allocated to the Conventional Therapy Group will be treated according to the assistant team of the Emergency Unit, where will be measured the following parameters: invasive or non-invasive blood pressure (decided by the assistant team), peripheral oximetry, heart and respiratory rate, urinary output, in association with clinical history, complete physical examination and laboratory and imaging tests.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Goal-Directed Therapy","Patients will be monitored by the ClearSight™ System (Edwards Life Sciences, Irvine, CA, USA) in the first 24 hours, where the parameters Cardiac Index (CI), Stroke Volume (SV), Systolic Blood Pressure (SBP) and Mean Arterial Pressure (MAP) will be acquired continuously. The treatment goal will be to keep the CI greater than or equal to 2.2 L\u002Fmin\u002Fm2, the SV greater than or equal to 35 mL\u002Fbeat, and the SBP greater than or equal to 90 mmHg and\u002For the MAP greater than or equal to 65 mmHg.\n\nIf the CI is below 2.2 L\u002Fmin\u002Fm2 and the SV less than 35 mL\u002Fbeat, an aliquot of 500 mL of crystalloid solution will be administered; if there is not an increase by 10% in the CI and SV values, a new aliquot of 250 mL may be administered; if this 10% increase does not occur for at least 20 minutes, inotropic medications will be started, with doses titrated periodically. If the pre-established goal is not reached, it is suggested to consider transfusion of a concentrated red blood cell.",[9],[26],"ClearSight™ System",[28],{"name":29,"affiliation":5,"role":30},"Ludhmila A Hajjar, MD, PhD","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","+55 11 26615795","ludhmila@usp.br",{"name":37,"role":33,"phone":34,"phoneExt":18,"email":38},"ARO F InCor, MD","aro@incor.usp.br",[40],{"facility":41,"status":42,"city":43,"state":18,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Instituto do Coração","RECRUITING","São Paulo","05403-000","Brazil","BR",{"type":48,"coordinates":49},"Point",[50,51],-46.63611,-23.5475,{"lat":51,"lon":50},[54],{"name":55,"role":33,"phone":56,"phoneExt":18,"email":35},"Ludhmila Hajjar, MD, PhD","+55 11 2661-4246",{"type":30,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Ludhmila Abrahão Hajjar MD, PhD","Associate Professor",[61],{"name":62,"class":6},"Instituto Dante Pazzanese de Cardiologia","100465104","non-invasive-goal-directed-therapy-on-circulatory-shock-100465104",false,"NCT05336357","Non-invasive Goal-directed thErapy oN cIrcUlatory Shock","The Effect of Non-invasive Hemodynamic Goal-directed Therapy on the Incidence of Acute Kidney Injury in Circulatory Shock: a Randomized Clinical Trial","GENIUS","Inclusion Criteria\n\n* Age \\> 18 years;\n* Patients admitted to Emergency Units, Intensive Care Units, and Wards within 3 hours of the diagnosis of Septic Shock:\n* Systolic Blood Pressure (SBP) \\\u003C 90 mmHg and\u002For Mean Arterial Pressure (MAP) \\\u003C 65 mmHg (with or without norepinephrine at a dose less than 0.5 mcg\u002Fkg\u002Fmin) + Clinical signs of infection and at least one of the following:\n\n  * Lactate \\> 2 mEq\u002FL;\n  * Oliguria (urine output \\\u003C 0.5 mL\u002Fkg\u002Fh for at least 6 hours);\n  * Neurological changes (mental confusion, decreased level of consciousness, psychomotor agitation, temporal-spatial disorientation);\n  * Capillary refill time \\> 3 s (after digital compression for 10 seconds);\n  * Poor skin perfusion.\n* Signed Informed Consent Form.\n\nExclusion Criteria\n\n* Hospital admission time greater than 24 hours\n* Significant edema in the fingers\n* Severe peripheral vasoconstriction\n* Use of Norepinephrine at a dose greater than or equal to 0.5 mcg\u002Fkg\u002Fmin\n* Presence of significant Aortic Insufficiency\n* Patients undergoing Renal Replacement Therapy\n* Patients with ST-segment elevation Myocardial Infarction\n* Patients requiring Invasive Mechanical Ventilation\n* Patients already participating in another study","ALL","18 Years",{"count":74,"type":75},380,"ESTIMATED","INTERVENTIONAL",[78],"NA","Circulatory shock occurs when the oxygen supply to the tissues decreases, leading to cellular damage and affecting about one-third of patients admitted to Intensive Care Units (ICUs). Cardiac Output (CO) is defined as the volume of blood ejected by the left ventricle per minute and is a crucial hemodynamic parameter for monitoring patients with signs of circulatory shock. However, this parameter is underutilized in patients treated in Emergency Units because its measurement typically involves invasive methods, which are not commonly available in this setting. Any method capable of measuring CO without the need for pulmonary artery catheter insertion is referred to as minimally invasive CO monitoring. Evaluating these parameters allows for a quicker determination of the etiology of circulatory shock, enabling the early initiation of goal-directed therapy. Goal-directed therapy has been proven effective in reducing morbidity and mortality, ICU length of stay, and mechanical ventilation duration in ICU patients who respond to fluid resuscitation. Currently, there are no data on the impact of a hemodynamic optimization strategy in patients during the early hours of shock.\n\nThe objective is to assess whether goal-directed hemodynamic therapy, through non-invasive hemodynamic monitoring, reduces the time required for hemodynamic resuscitation in patients with septic shock. A multicenter, randomized, open-label study will be conducted in Emergency Units, Intensive Care Units, and Hospital Wards.\n\nPatients over 18 years old admitted with signs of septic shock (defined as systolic blood pressure less than 90 mmHg and\u002For mean arterial pressure less than 65 mmHg, along with at least one of the following criteria: lactate greater than 2 mEq\u002FL, oliguria, neurological alteration, or capillary refill time greater than 3 seconds) will be included Participants will be randomized in a 1:1 ratio into two groups. In the Goal-Directed Therapy Group, patients will be monitored using the HemoSphere HPI™ (Edwards Life Sciences, Irvine, CA, USA), where parameters such as cardiac index (CI), stroke volume (SV), systolic blood pressure (SBP), mean arterial pressure (MAP), and HPI will guide medical management. In the Conventional Therapy Group, patients will be evaluated with the standard hemodynamic monitoring equipment typically found in emergency units..",[81],"Hemodynamics Instability",[83,84,85],"Shock","Sepsis","Early Goal Directed Therapy","2024-08-22",{"date":88,"type":89},"2024-08-26","ACTUAL",{"date":91,"type":89},"2024-02-20",{"date":93,"type":75},"2026-10-30",{"name":5,"class":6},1]