[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100377988":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":42,"centralContacts":46,"locations":51,"responsibleParty":109,"collaborators":111,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":33,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":33,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":144,"overallStatus":75,"whyStopped":33,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Columbia University","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Liberal IV Fluid","ACTIVE_COMPARATOR","* Maintenance fluid rate calculated by 4-2-1 formula for patients \\\u003C110kg: 4 mL\u002Fkg for first 0-10kg + 2 mL\u002Fkg for 11-20kg + 1 mL\u002Fkg for each kg \\>20kg\n* Patients \\>110kg maintenance 150 mL\u002Fhr\n* Bolus Criteria: change in 1 of: \\>20% decrease in systolic blood pressure 50th percentile for age and sex, \\>20% increase in heart rate over 50th percentile for age, base excess \\> -5mmol\u002FL, blood lactate \\>2mmol\u002FL, AND urine output (UO) \\\u003C1 mL\u002Fkg\u002Fhr if \\\u003C50kg or \\\u003C50 mL\u002Fhr if \\>50kg\n* If criteria met: bolus 20 mL\u002Fkg if \\\u003C50kg or 1 L if ≥50 kg\n* For transfusion: give 10 mL\u002Fkg packed red blood cells, platelets, or fresh frozen plasma up to 250 mL. If \\>25kg give 250 mL.\n* Diuresis- after minimum 24hrs: if UO \\\u003C2 mL\u002Fkg\u002Fhr (or \\\u003C100 mL\u002Fhr if \\>50 kg) continue maintenance rate and bolus per initial phase. If UO \\>2 mL\u002Fkg\u002Fhr (or \\>100 mL\u002Fhr if \\>50kg), and lactate, systolic blood pressure, heart rate, creatinine are normal then lower IV fluid rate to ½ maintenance rate and then to \"keep vein open\" once on regular feeds",[13,14,15,16],"Other: Balanced crystalloid solution volume administration","Other: Packed Erythrocytes Units, Blood Product Unit volume","Other: Plasma volume","Other: Platelets volume",{"label":18,"type":19,"description":20,"interventionNames":21},"Restricted IV Fluid","EXPERIMENTAL","* Maintenance fluid rate calculated by 70% of 4-2-1 formula if \\\u003C110 kg: 4 mL\u002Fkg for first 0-10 kg, + 2 mL\u002Fkg for 11-20 kg, + 1 mL\u002Fkg for every kg \\>20 kg\n* Patients \\>110 kg: maintenance is 105 mL\u002Fhr\n* If same bolus criteria met: 10 mL\u002Fkg for patients \\\u003C50kg, or 500 mL if ≥50 kg\n* If meet transfusion criteria: transfuse 10 mL\u002Fkg with packed red blood cells, platelets, or fresh frozen plasma by weight up to 250 mL. Patients \\>25 kg get 250 mL per transfusion\n* Diuresis (after minimum 24 hrs): if UO \\\u003C1 mL\u002Fkg\u002Fhr (or \\\u003C50 mL\u002Fhr if \\>50 kg) then continue IV fluids at maintenance rate and bolus as needed. If UO 1-2 mL\u002Fkg\u002Fhr (or 50-100 mL\u002Fhr if \\>50 kg) then decrease IV rate to ½ maintenance rate. If UO \\>2 mL\u002Fkg\u002Fhr (or \\>100 mL\u002Fhr if \\>50 kg), and Lactate, systolic blood pressure, heart rate, creatinine normal then reduce to \"keep vein open\" and consider Furosemide for goal UO \\>2-4 mL\u002Fkg\u002Fhr (100-200 mL\u002Fhr if \\>50 kg) until euvolemic",[13,14,15,16],[23,29,34,38],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Balanced crystalloid solution volume administration","Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.",[9,18],[28],"lactated ringers",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Packed Erythrocytes Units, Blood Product Unit volume","For patients designated as Bleeding, where hemoglobin \\\u003C7 then patient will be transfused 10 mL\u002Fkg up to 250 mL\u002Ftransfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL\u002Fkg.",[9,18],null,{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Plasma volume","For patients designated as Bleeding, where International Normalized Ratio (INR) \\> 1.5 then patient will be transfused 10 mL\u002Fkg up to 250 mL\u002Ftransfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL\u002Fkg.",[9,18],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":33},"Platelets volume","For patients designated as Bleeding, where platelets \\\u003C 50,000 then patient will be transfused 10 mL\u002Fkg up to 250 mL\u002Ftransfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL\u002Fkg.",[9,18],[43],{"name":44,"affiliation":5,"role":45},"Vincent P Duron, MD","PRINCIPAL_INVESTIGATOR",[47],{"name":44,"role":48,"phone":49,"phoneExt":33,"email":50},"CONTACT","212-342-8586","vd2312@cumc.columbia.edu",[52,73,84,96],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"John R. Oishei Children's Hospital of Buffalo","NOT_YET_RECRUITING","Buffalo","New York","14203","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-78.87837,42.88645,{"lat":64,"lon":63},[67,70],{"name":68,"role":48,"phone":33,"phoneExt":33,"email":69},"Shahzad Waheed, MD","SBWaheed@kaleidahealth.org",{"name":71,"role":48,"phone":33,"phoneExt":33,"email":72},"Andrew Nordin, MD","ANordin@KaleidaHealth.org",{"facility":74,"status":75,"city":56,"state":56,"zip":76,"country":58,"countryCode":59,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Columbia University Irving Medical Center NewYork-Presbyterian Morgan Stanley Children's Hospital","RECRUITING","10032",{"type":61,"coordinates":78},[79,80],-74.00597,40.71427,{"lat":80,"lon":79},[83],{"name":44,"role":48,"phone":49,"phoneExt":33,"email":50},{"facility":85,"status":75,"city":86,"state":56,"zip":87,"country":58,"countryCode":59,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"University of Rochester, Golisano Children's Hospital","Rochester","14642",{"type":61,"coordinates":89},[90,91],-77.61556,43.15478,{"lat":91,"lon":90},[94],{"name":95,"role":48,"phone":33,"phoneExt":33,"email":33},"David Darcy",{"facility":97,"status":75,"city":98,"state":99,"zip":100,"country":58,"countryCode":59,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Le Bonheur Children's Hospital","Memphis","Tennessee","38103",{"type":61,"coordinates":102},[103,104],-90.04898,35.14953,{"lat":104,"lon":103},[107],{"name":108,"role":48,"phone":33,"phoneExt":33,"email":33},"Regan F Williams, MD, MS",{"type":110,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[112,114,116,118],{"name":113,"class":6},"Northwell Health",{"name":115,"class":6},"Johns Hopkins University",{"name":117,"class":6},"Cornell University",{"name":119,"class":120},"Childress Institute for Pediatric Trauma","UNKNOWN","100377988","effect-of-giving-reduced-fluid-in-children-after-trauma-100377988",false,"NCT04201704","Effect of Giving Reduced Fluid in Children After Trauma","Effect of Restricted Fluid Management Strategy on Outcomes in Critically Ill Pediatric Trauma Patients: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Trauma patients older than 6 months and younger than 15 years admitted to the pediatric intensive care unit (PICU)\n* Patients admitted to the PICU directly from the Emergency Department (ED)\n* Patients admitted to the PICU from the operating room (OR)\n* Patients transferred to PICU from outside facility ED (need to have been in ED 12 hours or less)\n\nExclusion Criteria:\n\n* Patients transferred to PICU from outside PICU or inpatient floor\n* Patients transferred to PICU from outside facility ED if \\>12 hours\n* Patients expected to be discharged from the PICU within 24 hours\n* Patient with congenital heart disease as defined by a congenital cardiac defect requiring surgery or medication\n* Patient with diagnosis of chronic cardiac condition (e.g. hypertension, cardiac arrhythmia)\n* Patients with chronic kidney disease as defined by an abnormality of kidney structure or function, present for more than 3 months, with implications to health\n* Post-operative transplant, cardiac, and neurosurgical patients\n* Patients with traumatic brain injury\n* Patients with any disease that may affect baseline blood pressure and heart rate (endocrine disorders, certain genetic disorders, mitochondrial diseases)\n* Hypotension requiring vasopressor therapy\n* If massive transfusion protocol initiated","ALL","6 Months","15 Years",{"count":132,"type":133},250,"ESTIMATED","INTERVENTIONAL",[136],"NA","This study is designed to help decide how much intravenous (IV) fluid should be given to pediatric trauma patients. No standard currently exists for managing fluids in critically ill pediatric trauma patients, and many fluid strategies are now in practice. For decades, trauma patients got high volumes of IV fluid. Recent studies in adults show that patients actually do better by giving less fluid. The investigators do not know if this is true in children and this study is designed to answer that question and provide guidelines for IV fluid management in children after trauma.",[139,140,141,142,143],"Critical Illness","Pediatrics","General Surgery","Fluid Therapy","Wounds and Injuries",[142,145,146,143,147,148,149,150,151,152,153,154,155,156,157],"Intensive Care Units, Pediatric","Critical Care","Multiple Trauma","Treatment Outcome","Postoperative Complications","Resuscitation","Hemodynamics","Infusions, Intravenous","Isotonic Solutions","Crystalloid Solutions","Diuretics","Organism Hydration Status","Body Water","2026-05-04",{"date":160,"type":161},"2026-05-07","ACTUAL",{"date":163,"type":161},"2018-08-27",{"date":165,"type":133},"2027-09",{"name":5,"class":6},4]