[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552877":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":72,"studyPopulation":72,"armGroups":80,"interventions":93,"overallOfficials":72,"centralContacts":103,"locations":109,"responsibleParty":174,"collaborators":178,"id":188,"slug":189,"hasResults":190,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":190,"sex":196,"minAge":197,"maxAge":198,"enrollmentInfo":199,"targetDuration":72,"studyType":202,"phases":203,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":216,"whyStopped":72,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"Hospital General Pediátrico Niños de Acosta Ñu","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":72},[9],{"measure":10,"description":11,"timeFrame":12},"Survival free of organ support at 28 days","Organ support will be defined as invasive ventilation support, cardiovascular organ support (inotropic or ECMO support), and renal replacement therapy","From time of randomization until 28 days, if death occurs, time is set to 0 days",[14,18,21,24,28,31,34,38,41,45,49,52,55,58,60,63,66,69],{"measure":15,"description":16,"timeFrame":17},"Recuitment rates","Secondary feasibility outcome 1","12 months",{"measure":19,"description":20,"timeFrame":17},"Proportion of eligible randomised","Other feasibility 2",{"measure":22,"description":23,"timeFrame":17},"Proportion of eligible consented using perspective consent and consent to continue","Other feasibility 3",{"measure":25,"description":26,"timeFrame":27},"Time to initiation of inotropes between the control and the early inotrope arm","Other feasibility 4","24 hours",{"measure":29,"description":30,"timeFrame":27},"Amount of fluid delivered (in mLs per kg) during the first 24 h between the control and the early inotrope arm","Other feasibility 5",{"measure":32,"description":33,"timeFrame":17},"Protocol violations","Other feasibility 6. Percentage of patients not treated according to the assigned group.",{"measure":35,"description":36,"timeFrame":37},"Survival free of inotrope support at 7 days","Secondary exploratory clinical outcome 1","7 days",{"measure":39,"description":40,"timeFrame":37},"Survival free of invasive ventilation support at 7 days","Secondary exploratory clinical outcome 2",{"measure":42,"description":43,"timeFrame":44},"28-day mortality","Secondary exploratory clinical outcome 3","From time of randomization until 28 days",{"measure":46,"description":47,"timeFrame":48},"Survival free of PICU censored at 28 days","Secondary exploratory clinical outcome 4","28 days",{"measure":50,"description":51,"timeFrame":48},"PICU length of stay","Secondary exploratory clinical outcome 5",{"measure":53,"description":54,"timeFrame":48},"Hospital length of stay","Secondary exploratory clinical outcome 6",{"measure":56,"description":57,"timeFrame":48},"Functional Status Score at 28 days","Secondary exploratory clinical outcome 7",{"measure":59,"description":57,"timeFrame":48},"Modified Pediatric Overall Performance Category at 28 days",{"measure":61,"description":62,"timeFrame":27},"Amount of fluid (mLs per kg) received during the first hour, and by 4, 12, and 24 hour post enrolment","Secondary exploratory clinical outcome 8",{"measure":64,"description":65,"timeFrame":27},"Proportion of patients with lactate \u003C2 mmol\u002Fl at 6, 12, and 24 hours post enrolment","Secondary exploratory clinical outcome 9",{"measure":67,"description":68,"timeFrame":27},"Time to reversal of tachycardia during the first 24 h","Secondary exploratory clinical outcome 10",{"measure":70,"description":71,"timeFrame":48},"Time to shock reversal, defined as cessation of inotropes for at least 4 h censored at 28 days","Secondary exploratory clinical outcome 11",null,{"allocation":74,"interventionModel":75,"interventionModelDescription":76,"primaryPurpose":77,"observationalModel":72,"timePerspective":72,"maskingInfo":78},"RANDOMIZED","PARALLEL","The study is a two-armed control study. One of the arms is the control group, so a group of participants, that is being treated with the standard therapy. The other arm is the intervention group, a group of participants that is being treated with adrenaline. It will be random which child is assigned to which group, this insures that the study is not biased.","TREATMENT",{"masking":79,"maskingDescription":72,"whoMasked":72},"NONE",[81,87],{"label":82,"type":83,"description":84,"interventionNames":85},"Control group","ACTIVE_COMPARATOR","Sepsis will be treated with a standardized therapy protocol, where participants will receive fluids for resuscitation. Specifically, they will receive 40-60 ml\u002Fkg of fluids before the initiation of inotropes",[86],"Other: Fluid",{"label":88,"type":89,"description":90,"interventionNames":91},"Intervention group","EXPERIMENTAL","Sepsis will be treated with early inotropes, where participants will receive adrenaline after the first bolus of 20 ml\u002Fkg",[92],"Drug: Adrenalin",[94,98],{"type":6,"name":95,"description":96,"armGroupLabels":97,"otherNames":72},"Fluid","Sepsis will be treated with standardized therapy protocol, where participants receive fluids (balanced or non-balanced crystalloids, or colloids) to be resuscitated. Specifically, they will receive 40-60 ml\u002Fkg of fluids before the initiation of inotropes.",[82],{"type":99,"name":100,"description":101,"armGroupLabels":102,"otherNames":72},"DRUG","Adrenalin","Sepsis will be treated with early inotropes, where participants will receive adrenaline at a dose of 0.05 - 0.1 mcg\u002Fkg\u002Fmin via peripheral intravenous, intraosseous, or central venous routes after the first fluid bolus of 20 ml\u002Fkg",[88],[104],{"name":105,"role":106,"phone":107,"phoneExt":72,"email":108},"Natalia Lopera, MD","CONTACT","+57 3122978381","natalialoperam@gmail.com",[110,128,144,160],{"facility":111,"status":72,"city":112,"state":72,"zip":72,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":120,"contacts":121},"Hospital de Niños \"Dr. Orlando Alassia\"","Santa Fe","Argentina","AR",{"type":116,"coordinates":117},"Point",[118,119],-60.70868,-31.64881,{"lat":119,"lon":118},[122,126],{"name":123,"role":106,"phone":124,"phoneExt":72,"email":125},"Rodolfo Pacce, MD","+54 9 3424350350","rodolfopacce2000@yahoo.com.ar",{"name":123,"role":127,"phone":72,"phoneExt":72,"email":72},"PRINCIPAL_INVESTIGATOR",{"facility":129,"status":72,"city":130,"state":72,"zip":72,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Hospital Regional San Juan De Dios Tarija","Tarija","Bolivia","BO",{"type":116,"coordinates":134},[135,136],-64.72956,-21.53549,{"lat":136,"lon":135},[139,143],{"name":140,"role":106,"phone":141,"phoneExt":72,"email":142},"Nils Casson, MD","+591 7 6187393","nilsjefe1@hotmail.com",{"name":140,"role":127,"phone":72,"phoneExt":72,"email":72},{"facility":145,"status":72,"city":146,"state":72,"zip":72,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Hospital De Clínicas","Asunción","Paraguay","PY",{"type":116,"coordinates":150},[151,152],-57.647,-25.28646,{"lat":152,"lon":151},[155,159],{"name":156,"role":106,"phone":157,"phoneExt":72,"email":158},"Ricardo Iramain, MD","+595 981300491","iramainricardo@gmail.com",{"name":156,"role":127,"phone":72,"phoneExt":72,"email":72},{"facility":161,"status":72,"city":162,"state":72,"zip":72,"country":147,"countryCode":148,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Hospital Niños de Acosta Ñu","San Lorenzo",{"type":116,"coordinates":164},[165,166],-57.50879,-25.33968,{"lat":166,"lon":165},[169,173],{"name":170,"role":106,"phone":171,"phoneExt":72,"email":172},"Viviana Pavlicich, MD","+595 971206043","p_viviana@hotmail.com",{"name":170,"role":127,"phone":72,"phoneExt":72,"email":72},{"type":175,"investigatorFullName":176,"investigatorTitle":177,"investigatorAffiliation":5,"oldNameTitle":72,"oldOrganization":72},"SPONSOR_INVESTIGATOR","NATALIA LOPERA MUNERA","Pediatrician, principal investigator",[179,181,183,186],{"name":180,"class":6},"University Children's Hospital, Zurich",{"name":182,"class":6},"Universidad Nacional del Nordeste, Argentina",{"name":184,"class":185},"Instituto Latino Americano de Sepse","UNKNOWN",{"name":187,"class":6},"Hospital Pablo Tobón Uribe","100552877","phase-2-early-resuscitation-in-paediatric-sepsis-using-inotropes-100552877",false,"NCT06478797","Early Resuscitation in Paediatric Sepsis Using Inotropes","Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)","ANDES-CHILD","Inclusion Criteria:\n\n* 28 days and \\\u003C18 years\n* Treated for sepsis\n* Received at least 20 ml\u002Fkg fluid bolus in the last 4 hours and clinician decides to continue treating signs of shock\n* Parental\u002Fcaregiver consent prior to or after enrolment\n\nExclusion Criteria:\n\n* Preterm babies born \\\u003C34 weeks gestation that have a corrected age of \\\u003C28 days\n* Received ≥ 40 mL\u002Fkg of fluid boluses during the 4 h pre-enrolment\n* Inotrope infusion commenced pre-enrolment\n* Lack of access (intraosseous, central venous or peripheral) to administer fluids and\u002For inotropes after 60min of enrolment\n* Cardiomyopathy or chronic cardiac failure\n* Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment\n* Known chronic renal failure (defined as requiring renal replacement therapy)\n* Known chronic hepatic failure\n* Palliative care patient\u002Fpatient with limitation of treatment (not for inotropes, cardiopulmonary resuscitation, extracorporeal membrane oxygenation, intubation or ventilation)\n* Cardiopulmonary arrest in the past 2 h requiring cardiopulmonary resuscitation of \\>2min duration, or death is deemed to be imminent or inevitable during this admission.\n* Major bleeding with haemorrhagic shock\n* Sepsis is not likely to be the cause of shock\n* Previous enrollment in ANDES-CHILD","ALL","28 Days","18 Years",{"count":200,"type":201},40,"ESTIMATED","INTERVENTIONAL",[204],"PHASE2","Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40-60 mL\u002Fkg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. The investigators hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, the investigators describe the protocol of the Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)",[207],"Sepsis",[209,210,211,212,213,214,215],"pediatric sepsis","septic shock","inotropes","adrenaline","emergency department","fluid","child","NOT_YET_RECRUITING","2024-06-24",{"date":219,"type":220},"2024-06-27","ACTUAL",{"date":222,"type":201},"2024-07",{"date":224,"type":201},"2025-12",{"name":176,"class":6},4]