[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525210":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":50,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":78,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Fundación Santa Fe de Bogota","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"EaDyn weaning arm","EXPERIMENTAL","In the EaDyn weaning arm of the study, dynamic arterial elastance (EaDyn) will be utilized as a specialized hemodynamic tool to guide the gradual reduction of vasopressor support in patients diagnosed with septic shock. EaDyn, a measure of the relationship between arterial pressure and stroke volume variation over the cardiac cycle, provides valuable insights into vascular tone and cardiac performance",[13],"Procedure: EaDyn Weaning Arm:",{"label":15,"type":16,"description":17,"interventionNames":18},"PAM weaning arm","ACTIVE_COMPARATOR","In the PAM (Mean Arterial Pressure) weaning arm of the study, mean arterial pressure (MAP) will be used as the primary parameter to guide the gradual reduction of vasopressor support in patients diagnosed with septic shock. Mean arterial pressure represents the average pressure in the arteries during one cardiac cycle and is a crucial indicator of perfusion to vital organs. Participants in this group will be monitored continuously for their MAP values, allowing real-time assessment of their hemodynamic status.",[19],"Procedure: PAM Weaning Arm:",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","EaDyn Weaning Arm:","The initiation of vasopressor weaning coincides with the beginning of the stabilization phase, which occurs when patients achieve a MAP \\>75 mmHg, a cardiac index (CI) \\>2.5 L\u002Fmin\u002Fm², and a lactate level \\\u003C2 mmol\u002FL. The norepinephrine dose will be gradually tapered, decreasing by 0.02 mcg\u002Fkg\u002Fmin every 30 minutes. In the experimental group, vasopressor weaning is guided by the EaDyn value. Weaning can proceed as long as the EaDyn remains at or above 0.90. However, if the value drops below 0.90, the weaning process halts, and the norepinephrine dose is reverted to the last dose where the EaDyn value was ≥ 0.90. Regardless of the EaDyn value, any patient experiencing a MAP decline below 50 mmHg will be withdrawn from the study. Should the MAP range between 50 mmHg and 69 mmHg, a fluid challenge of 250 mL of isotonic crystalloid must be administered before weaning continues.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"PAM Weaning Arm:","The initiation of vasopressor weaning coincides with the beginning of the stabilization phase, which occurs when patients achieve a MAP \\>75 mmHg, a cardiac index (CI) \\>2.5 L\u002Fmin\u002Fm², and a lactate level \\\u003C2 mmol\u002FL. The norepinephrine dose will be gradually tapered, decreasing by 0.02 mcg\u002Fkg\u002Fmin every 30 minutes. In the control group, vasopressor weaning progresses as long as the MAP remains at or above 70 mmHg. If the MAP falls between 50 and 69 mmHg, preload dependency is reassessed. Upon confirmation, a new fluid challenge is administered; vasopressor weaning halts, and the vasopressor dose reverts to its prior value. The weaning process can continue as long as the patient's MAP remains above 50 mmHg. If the MAP drops below this threshold, the patient exits the study.",[15],[32],{"facility":33,"status":26,"city":34,"state":26,"zip":26,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Jorge Iván Alvarad","Bogotá","Colombia","CO",{"type":38,"coordinates":39},"Point",[40,41],-74.08175,4.60971,{"lat":41,"lon":40},[44,48],{"name":45,"role":46,"phone":26,"phoneExt":26,"email":47},"Jorge Alvarado","CONTACT","jialvarados@unal.edu.co",{"name":26,"role":46,"phone":49,"phoneExt":26,"email":26},"3017858459",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Jorge Iván Alvarado","Anesthesiologist","100525210","evaluating-dynamic-arterial-elastance-in-septic-shock-patients-100525210",false,"NCT06118775","Evaluating Dynamic Arterial Elastance in Septic Shock Patients.","Assessment of the Effectiveness and Safety of Dynamic Arterial Elastance in Weaning Vasopressor Support in Patients with Septic Shock: a Randomized Controlled Clinical Trial At Santa Fé Foundation in Bogotá","EaDyn","Inclusion Criteria:\n\n* ≥ 18 years of age.\n* Admission to the ICU.\n* Septic shock defined according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).\n* Hypotension requiring vasopressor support to maintain a MAP ≥ 65 mmHg.\n* SOFA score ≥ 4.\n* Vasopressor support duration ≥ 4 hours.\n* Patients requiring mechanical ventilation.\n* Patients who have reached the hemodynamic stabilization phase and are ready to begin the vasopressor weaning process with norepinephrine, defined as: mean arterial pressure (MAP) \\> 75 mmHg, cardiac index (CI) \\> 2.5 L\u002Fmin\u002Fm², and lactate level \\\u003C 2 mmol\u002FL.\n\nExclusion Criteria:\n\n* Pregnant individuals.\n* Hemodynamic instability due to cardiac arrhythmias.\n* Hepatic cirrhosis.\n* Kidney or liver transplant.\n* High probability of mortality within 24 hours, according to medical judgment.\n* Left ventricular ejection fraction (LVEF) less than 50%.\n* Right ventricular dysfunction, defined as a TAPSE (Tricuspid Annular Plane Systolic Excursion) measurement of less than 1.6 cm.\n* Patients spontaneously breathing.","ALL","18 Years","120 Years",{"count":66,"type":67},114,"ESTIMATED","INTERVENTIONAL",[70],"NA","Assess the effectiveness and safety of using dynamic arterial elastance as a tool for weaning vasopressor support in patients with septic shock, compared to a control group",[73],"Septic Shock",[75,76,77],"Dynamic arterial elastance (EaDyn).","vasopressor weaning.","septic shock.","NOT_YET_RECRUITING","2025-02-20",{"date":81,"type":82},"2025-02-24","ACTUAL",{"date":84,"type":67},"2025-03-01",{"date":86,"type":67},"2026-07-01",{"name":5,"class":6},1]