[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588171":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":43,"responsibleParty":82,"collaborators":33,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":33,"enrollmentInfo":94,"targetDuration":33,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":106,"overallStatus":62,"whyStopped":33,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Mahidol University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"the standard of care group","ACTIVE_COMPARATOR","The standard of care group will be treated according to according to septic shock guidelines 2021; In brief A vasopressor with optimal ideal fluid (at least 30 ml\u002Fkg) will be given to achieve the hemodynamic target (MAP ≥ 65 mm Hg) by fluid challenge technique guided by MAP and central venous pressure (CVP) changes after fluid challenge. Fluid-responsive tests can be used as a subsidiary, depending on the attending physician. Early Norepinephrine (NE) infusion can be used with a standard dose of 0.05 mcg\u002Fk\u002Fmin and titrated at the rate of 0.01-0.02 mcg\u002Fkg\u002Fmin every 10 min until 0.25 mcg\u002Fkg\u002Fmin was achieved; then, the second line vasopressor will be added and adjusted to the target of vasopressor. Hydrocortisone can be given according to septic shock guidelines.",[13],"Other: The standard care for septic shock",{"label":15,"type":16,"description":17,"interventionNames":18},"AFM and Eadyn - guided resuscitation group","EXPERIMENTAL","Patients randomized to this arm are treated with the standard of care for patients with septic shock as described for 'the standard of care' arm, along with the AFM and Eadyn - guided resuscitation group, as detailed under 'Interventions'",[19,13],"Device: The AFM and Eadyn - guided resuscitation group",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","The AFM and Eadyn - guided resuscitation group","A fluid challenge using a stroke volume change prediction (∆SVpredict) and Eadyn guide. If the ∆SVpredict is more than 10%, isotonic crystalloid of 500 ml will be administered in 30 minutes, and the machine's response will be awaited. If ∆SVpredict is still more than 10%, continuous fluid loading was reapplied until SVV was less than 10% (fluid therapy will be stopped if ∆SVpredict is less than 10%) and dynamic arterial elastance (EAdyn) reaches the goal of 0.8-1.0 along with a vasopressor will be administered and titrated every 10 minutes until the target MAP \\> 65 mmHg is reached. After MAP of 65 achieved, tissue perfusion including urine output, capillary refill time, and serum lactate will be assessed",[15],[27,28],"hemosphere","dynamic arterial elastance",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"The standard care for septic shock","The standard of care group will be treated according to according to septic shock guidelines 2021; In brief A vasopressor with optimal ideal fluid (at least 30 ml\u002Fkg) will be given to achieve the hemodynamic target (MAP ≥ 65 mm Hg) by fluid challenge technique guided by MAP and central venous pressure (CVP) changes after fluid challenge. Fluid-responsive tests can be used as a subsidiary, depending on the attending physician. Early Norepinephrine (NE) infusion can be used with a standard dose of 0.05 mcg\u002Fk\u002Fmin and titrated at the rate of 0.01-0.02 mcg\u002Fkg\u002Fmin every 10 min until 0.25 mcg\u002Fkg\u002Fmin was achieved; then, the second line vasopressor will be added and adjusted to the target of vasopressor. Hydrocortisone can be given according to septic shock guidelines.\n\nAfter MAP of 65 achieved, tissue perfusion including urine output, capillary refill time, and serum lactate will be assessed",[15,9],null,[35,40],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Ranistha Ratanarat, MD","CONTACT","+66 2419 7767","ranittha@gmail.com",{"name":41,"role":37,"phone":38,"phoneExt":33,"email":42},"Nuwara Pornawalai, MD","nuwara.por@gmail.com",[44,60,73],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Faculty of Medicine Siriraj Hospital","NOT_YET_RECRUITING","Bangkok Noi","Bangkok","10700","Thailand","TH",{"type":53,"coordinates":54},"Point",[55,56],100.47798,13.76266,{"lat":56,"lon":55},[59],{"name":41,"role":37,"phone":38,"phoneExt":33,"email":42},{"facility":61,"status":62,"city":48,"state":33,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Siriraj Hospital, Mahidol University","RECRUITING",{"type":53,"coordinates":64},[65,66],100.50144,13.75398,{"lat":66,"lon":65},[69,72],{"name":36,"role":37,"phone":70,"phoneExt":33,"email":71},"+66896685287","ranittha@gmail.com; ranittha@hotmail.com",{"name":41,"role":37,"phone":33,"phoneExt":33,"email":42},{"facility":61,"status":62,"city":48,"state":33,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},{"type":53,"coordinates":75},[65,66],{"lat":66,"lon":65},[78,79,80],{"name":36,"role":37,"phone":70,"phoneExt":33,"email":71},{"name":41,"role":37,"phone":33,"phoneExt":33,"email":42},{"name":36,"role":81,"phone":33,"phoneExt":33,"email":33},"PRINCIPAL_INVESTIGATOR",{"type":83,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100588171","effect-of-dynamic-arterial-elastance-and-assisted-fluid-management-software-guided-resuscitation-in-septic-shock-pilot-study-100588171",false,"NCT06937918","Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study","Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Adjustment of Vasopressor and Fluid Therapy in Septic Shock Resuscitation; A Pilot Study","DAFM shock","Inclusion Criteria:\n\n* All Thai consecutive patients older than 18 years with a diagnosis of sepsis or septic shock in medical ICU, defined by clinically suspected or confirmed infection and MAP \\\u003C65 mmHg according to the criteria of the Surviving Sepsis Campaign 2021(11)with onset of shock in less than 24 hours.\n* Already receiving or planning for mechanical ventilation\n* Already receiving or planning for arterial catheter placement for invasive arterial pressure monitoring\n* All patients will receive an echocardiogram with a cut point of LVEF \\> 30% to be included in the study\n\nExclusion Criteria:\n\n* Active, immediate, life-threatening cardiac arrhythmia, defined as ventricular tachycardia and ventricular fibrillation\n* Acute cerebral vascular event, including both acute ischemic stroke or intracranial hemorrhage\n* Acute coronary syndrome\n* cardiogenic shock, acute heart failure\n* Severe asthma exacerbation\n* Fluid intolerance: hypoxemia (P:F ratio \\\u003C 150)\n* Life-threatening gastrointestinal hemorrhage\n* Pregnancy\n* Requirement for immediate surgery within 2 hours of randomization\n* Advanced-stage cancer with predicted survival of less than 6 months\n* Oliguric AKI with signs of volume overload\n\nWithdrawal or termination criteria\n\n* The patient and legal representative request for withdrawal\n* The attending physician requested a withdrawal","ALL","18 Years",{"count":95,"type":96},60,"ESTIMATED","INTERVENTIONAL",[99],"NA","To investigate the benefit of using the AFM and Eadyn-guided fluid and vasopressor therapy in septic shock resuscitation for mechanically ventilated patients compared with the standard of care. The investigators hypothesize that using the AFM and Eadyn-guided fluid\u002Fvasopressor titration in septic shock patients who underwent mechanical ventilation might reduce the time to shock reversal.",[102,103,104,105],"Critical Illness","Fluid Over-load","Dynamic Arterial Elastance","Septic Shock",[107,28,108,109,110,111],"critical illness","stroke volume change prediction","fluid overload","ischemic complication","septic shock","2025-04-22",{"date":114,"type":115},"2025-04-27","ACTUAL",{"date":117,"type":96},"2025-04-23",{"date":119,"type":96},"2028-04-08",{"name":5,"class":6},3]