[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456094":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":300,"collaborators":302,"id":343,"slug":344,"hasResults":345,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":345,"sex":351,"minAge":352,"maxAge":353,"enrollmentInfo":354,"targetDuration":25,"studyType":357,"phases":358,"briefSummary":360,"conditions":361,"keywords":364,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":381},{"fullName":5,"class":6},"University of Calgary","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hyperhydration","EXPERIMENTAL","In this study arm, all eligible children are admitted for the administration of intravenous fluids.\n\nThe following specifics will form the basis of the fluid management protocol:\n\n1. Reversal of dehydration: Initial ED rehydration strategies should focus on rapidly reversing dehydration.\n2. Infusion of 200% of maintenance fluids x 24 hours\n3. If hematocrit reduction \\\u003C 20% from initial value, repeat step #2 \\[infusion of 200% maintenance fluids x 24 hours\\].\n4. Oral fluids permitted ad lib.\n5. Once the target hematocrit reduction is achieved (20% decrement in initial HCT) AND a 10% weight gain, adjust total IV fluid volume to maintain targeted weight gain: insensible plus output (i.e., urine plus stool).",[13],"Other: Infusion of 200% maintenance fluids as balanced crystalloid IV solution",{"label":15,"type":16,"description":17,"interventionNames":18},"Conservative Fluid Management","ACTIVE_COMPARATOR","The conservative fluid management arm has been designed to align and integrate into existing local practice patterns. Implementation of this approach will allow institutions and their practitioners to choose their management of protocol eligible children. All children will undergo a protocolized baseline evaluation that includes reversal of dehydration (if present) and follow-up plan (see Pre-Pathway care). The fluid management decision in the ED (i.e., to treat dehydration) will be at the discretion of the clinical care team. In the absence of evidence of microangiopathy (i.e., normal urinalysis, LDH, hemoglobin and platelet counts, and creatinine concentrations), the decision to admit the child to hospital or discharge the child to home will be at the discretion of the clinical care team. If microangiopathy is present (i.e., abnormal urinalysis, LDH, hemoglobin or platelet counts, or creatinine concentrations) admission for monitoring will be required.",[19],"Other: Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Infusion of 200% maintenance fluids as balanced crystalloid IV solution","Infusion of 200% of maintenance fluids x 24 hours provided, ideally, as a balanced crystalloid (PlasmaLyteTM, Ringer's Lactate) IV solution. Electrolytes and dextrose may be administered as required and desired by the clinical care team; customized solutions are permitted if so desired. Intravenous fluid solutions containing \\\u003C 130 mEq\u002FL sodium may increase risk for hyponatremia and may be less effective in achieving intravascular volume expansion and should be avoided.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution","Administration of less than or equal to 110% of maintenance fluids as oral or balanced crystalloid IV solution.",[15],[31],{"name":32,"affiliation":5,"role":33},"Stephen Freedman, MDCM","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Study Manager","CONTACT","(801) 581-6410","hikostec@hsc.utah.edu",[41,55,65,75,84,94,104,114,124,134,143,153,163,173,182,191,201,211,221,230,240,250,260,272,281,291],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":25},"University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-86.80249,33.52066,{"lat":53,"lon":52},{"facility":56,"status":43,"city":57,"state":58,"zip":59,"country":47,"countryCode":48,"cosmosGeoPoint":60,"geoPoint":64,"contacts":25},"Arkansas Children's Hospital","Little Rock","Arkansas","72202",{"type":50,"coordinates":61},[62,63],-92.28959,34.74648,{"lat":63,"lon":62},{"facility":66,"status":43,"city":67,"state":68,"zip":69,"country":47,"countryCode":48,"cosmosGeoPoint":70,"geoPoint":74,"contacts":25},"University of California, San Diego","La Jolla","California","92093",{"type":50,"coordinates":71},[72,73],-117.2742,32.84727,{"lat":73,"lon":72},{"facility":76,"status":43,"city":77,"state":68,"zip":78,"country":47,"countryCode":48,"cosmosGeoPoint":79,"geoPoint":83,"contacts":25},"University of California, Davis","Sacramento","95817",{"type":50,"coordinates":80},[81,82],-121.4944,38.58157,{"lat":82,"lon":81},{"facility":85,"status":43,"city":86,"state":87,"zip":88,"country":47,"countryCode":48,"cosmosGeoPoint":89,"geoPoint":93,"contacts":25},"University of Colorado Denver","Denver","Colorado","80045",{"type":50,"coordinates":90},[91,92],-104.9847,39.73915,{"lat":92,"lon":91},{"facility":95,"status":43,"city":96,"state":97,"zip":98,"country":47,"countryCode":48,"cosmosGeoPoint":99,"geoPoint":103,"contacts":25},"Children's Research Institute","Washington D.C.","District of Columbia","20010",{"type":50,"coordinates":100},[101,102],-77.03637,38.89511,{"lat":102,"lon":101},{"facility":105,"status":43,"city":106,"state":107,"zip":108,"country":47,"countryCode":48,"cosmosGeoPoint":109,"geoPoint":113,"contacts":25},"Emory University","Atlanta","Georgia","30322",{"type":50,"coordinates":110},[111,112],-84.38798,33.749,{"lat":112,"lon":111},{"facility":115,"status":43,"city":116,"state":117,"zip":118,"country":47,"countryCode":48,"cosmosGeoPoint":119,"geoPoint":123,"contacts":25},"Indiana University Children's Hospital","Indianapolis","Indiana","47401",{"type":50,"coordinates":120},[121,122],-86.15804,39.76838,{"lat":122,"lon":121},{"facility":125,"status":43,"city":126,"state":127,"zip":128,"country":47,"countryCode":48,"cosmosGeoPoint":129,"geoPoint":133,"contacts":25},"University of Kentucky","Lexington","Kentucky","40526",{"type":50,"coordinates":130},[131,132],-84.47772,37.98869,{"lat":132,"lon":131},{"facility":135,"status":43,"city":136,"state":127,"zip":137,"country":47,"countryCode":48,"cosmosGeoPoint":138,"geoPoint":142,"contacts":25},"Norton Children's Hospital","Louisville","40202",{"type":50,"coordinates":139},[140,141],-85.75941,38.25424,{"lat":141,"lon":140},{"facility":144,"status":43,"city":145,"state":146,"zip":147,"country":47,"countryCode":48,"cosmosGeoPoint":148,"geoPoint":152,"contacts":25},"Children's Minnesota Hospital","Minneapolis","Minnesota","55404",{"type":50,"coordinates":149},[150,151],-93.26384,44.97997,{"lat":151,"lon":150},{"facility":154,"status":43,"city":155,"state":156,"zip":157,"country":47,"countryCode":48,"cosmosGeoPoint":158,"geoPoint":162,"contacts":25},"Washington University","St Louis","Missouri","63110",{"type":50,"coordinates":159},[160,161],-90.19789,38.62727,{"lat":161,"lon":160},{"facility":164,"status":43,"city":165,"state":166,"zip":167,"country":47,"countryCode":48,"cosmosGeoPoint":168,"geoPoint":172,"contacts":25},"Children's Hospital Medical Center","Cincinnati","Ohio","45229-3039",{"type":50,"coordinates":169},[170,171],-84.51439,39.12711,{"lat":171,"lon":170},{"facility":174,"status":43,"city":175,"state":166,"zip":176,"country":47,"countryCode":48,"cosmosGeoPoint":177,"geoPoint":181,"contacts":25},"University Hospitals Rainbow Babies & Children's Hospital","Cleveland","44106",{"type":50,"coordinates":178},[179,180],-81.69541,41.4995,{"lat":180,"lon":179},{"facility":183,"status":43,"city":184,"state":166,"zip":185,"country":47,"countryCode":48,"cosmosGeoPoint":186,"geoPoint":190,"contacts":25},"Nationwide Children's Hospital","Columbus","43205",{"type":50,"coordinates":187},[188,189],-82.99879,39.96118,{"lat":189,"lon":188},{"facility":192,"status":43,"city":193,"state":194,"zip":195,"country":47,"countryCode":48,"cosmosGeoPoint":196,"geoPoint":200,"contacts":25},"University of Oklahoma Health Sciences Center","Oklahoma City","Oklahoma","73104",{"type":50,"coordinates":197},[198,199],-97.51643,35.46756,{"lat":199,"lon":198},{"facility":202,"status":43,"city":203,"state":204,"zip":205,"country":47,"countryCode":48,"cosmosGeoPoint":206,"geoPoint":210,"contacts":25},"Oregon Health & Science University","Portland","Oregon","97239",{"type":50,"coordinates":207},[208,209],-122.67621,45.52345,{"lat":209,"lon":208},{"facility":212,"status":43,"city":213,"state":214,"zip":215,"country":47,"countryCode":48,"cosmosGeoPoint":216,"geoPoint":220,"contacts":25},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":50,"coordinates":217},[218,219],-79.93275,32.77632,{"lat":219,"lon":218},{"facility":222,"status":43,"city":223,"state":224,"zip":185,"country":47,"countryCode":48,"cosmosGeoPoint":225,"geoPoint":229,"contacts":25},"Vanderbilt Children's Hospital","Nashville","Tennessee",{"type":50,"coordinates":226},[227,228],-86.78444,36.16589,{"lat":228,"lon":227},{"facility":231,"status":43,"city":232,"state":233,"zip":234,"country":47,"countryCode":48,"cosmosGeoPoint":235,"geoPoint":239,"contacts":25},"Baylor College of Medicine","Houston","Texas","77030",{"type":50,"coordinates":236},[237,238],-95.36327,29.76328,{"lat":238,"lon":237},{"facility":241,"status":43,"city":242,"state":243,"zip":244,"country":47,"countryCode":48,"cosmosGeoPoint":245,"geoPoint":249,"contacts":25},"University of Utah","Salt Lake City","Utah","84112",{"type":50,"coordinates":246},[247,248],-111.89105,40.76078,{"lat":248,"lon":247},{"facility":251,"status":43,"city":252,"state":253,"zip":254,"country":47,"countryCode":48,"cosmosGeoPoint":255,"geoPoint":259,"contacts":25},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":50,"coordinates":256},[257,258],-122.33207,47.60621,{"lat":258,"lon":257},{"facility":261,"status":43,"city":262,"state":263,"zip":264,"country":265,"countryCode":266,"cosmosGeoPoint":267,"geoPoint":271,"contacts":25},"Alberta Children's Hospital","Calgary","Alberta","T2N 1N4","Canada","CA",{"type":50,"coordinates":268},[269,270],-114.08529,51.05011,{"lat":270,"lon":269},{"facility":273,"status":43,"city":274,"state":263,"zip":275,"country":265,"countryCode":266,"cosmosGeoPoint":276,"geoPoint":280,"contacts":25},"University of Alberta","Edmonton","T5J 4P6",{"type":50,"coordinates":277},[278,279],-113.46871,53.55014,{"lat":279,"lon":278},{"facility":282,"status":43,"city":283,"state":284,"zip":285,"country":265,"countryCode":266,"cosmosGeoPoint":286,"geoPoint":290,"contacts":25},"McMaster University","Hamilton","Ontario","L8S 4K1",{"type":50,"coordinates":287},[288,289],-79.84963,43.25011,{"lat":289,"lon":288},{"facility":292,"status":43,"city":293,"state":284,"zip":294,"country":265,"countryCode":266,"cosmosGeoPoint":295,"geoPoint":299,"contacts":25},"The Hospital for Sick Children","Toronto","M5G 1X8",{"type":50,"coordinates":296},[297,298],-79.39864,43.70643,{"lat":298,"lon":297},{"type":301,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[303,306,308,310,311,312,314,315,316,317,319,320,322,324,326,327,329,331,333,334,335,336,337,338,340,341],{"name":304,"class":305},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":307,"class":6},"Children's Hospital Medical Center, Cincinnati",{"name":309,"class":6},"Washington University School of Medicine",{"name":241,"class":6},{"name":251,"class":6},{"name":313,"class":6},"University of Colorado, Denver",{"name":105,"class":6},{"name":76,"class":6},{"name":231,"class":6},{"name":318,"class":6},"Indiana University",{"name":42,"class":6},{"name":321,"class":6},"Arkansas Children's Hospital Research Institute",{"name":323,"class":6},"Children's National Research Institute",{"name":325,"class":6},"Children's Hospitals and Clinics of Minnesota",{"name":212,"class":6},{"name":328,"class":6},"University of Louisville",{"name":330,"class":6},"University of Oklahoma",{"name":332,"class":6},"Oregon Health and Science University",{"name":66,"class":6},{"name":282,"class":6},{"name":292,"class":6},{"name":273,"class":6},{"name":125,"class":6},{"name":339,"class":6},"Case Western Reserve University",{"name":183,"class":6},{"name":342,"class":6},"Vanderbilt University Medical Center","100456094","hyperhydration-in-children-with-shiga-toxin-producing-e-coli-infection-100456094",false,"NCT05219110","Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection","Hyperhydration to Improve Kidney Outcomes in Children With Shiga Toxin-Producing E. Coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial","HIKO-STEC","Inclusion Criteria:\n\nIn order to be eligible to participate in this study (i.e., to be enrolled in the relevant institutional clinical care pathway), an individual must meet all of the following criteria:\n\n1. Aged 9.0 months to \\\u003C21 years at the time of informed consent.\n2. Evidence of high-risk STEC infecting pathogen defined by any of the following:\n\n   1. Bloody diarrhea within the preceding 7 days\n\n      * Positive STEC culture OR\n      * Positive antigen\u002Fpolymerase chain reaction test for toxin\u002Fgene type not otherwise specified OR\n   2. Bloody or Non-bloody diarrhea within the preceding 7 days\n\n      •Presumptive diagnosis of HUS\n      * (meeting all 3 HUS criteria - anemia, thrombocytopenia, and renal insufficiency) OR\n   3. Non-bloody or no diarrhea\n\n      * Positive STEC culture for high-risk strain (i.e., O103, O104, O111, O113, O121, O145 or O157) OR\n      * Positive antigen\u002Fpolymerase chain reaction test Stx2 toxin\u002Fgene\n\nExclusion Criteria:\n\nAll individuals meeting any of the exclusion criteria at baseline will be excluded from study participation.\n\n1. Presence of Advanced HUS defined by:\n\n   1. Hematocrit \\\u003C30% AND\n   2. Platelet count \\\u003C150 x 103\u002Fmm3 AND\n   3. Creatinine \\> 2.0 mg\u002FdL (177 µmol\u002FL)\n\n      * The presence of only 1 or 2 of these criteria will not result in patient exclusion, regardless of how close the 3rd criterion is to meeting the exclusion criteria.\n2. Prior episode of HUS or diagnosis of atypical HUS.\n3. Chronic disease limiting fluid volumes administered (e.g. impaired renal, liver, or cardiac function, chronic lung disease).\n4. Evidence of anuria (i.e., no urine output for \\> 24 hours).\n5. Hypoxemia requiring oxygen therapy\n6. Hypertensive emergency\n7. Greater than or equal to 10 days since onset of diarrhea or if no diarrhea then the onset of other symptoms.\n8. Patients with known pregnancy\n9. Patients or caregivers with language barriers impairing appropriate conduct of the study protocol.","ALL","9 Months","21 Years",{"count":355,"type":356},1040,"ESTIMATED","INTERVENTIONAL",[359],"NA","The objective of this study is to determine if early high volume intravenous fluid administration (hyperhydration) may be effective in mitigating or preventing complications of shiga toxin-producing E. coli (STEC) infection in children and adolescents when compared with traditional approaches (conservative fluid management).",[362,363],"Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection","Hemolytic-Uremic Syndrome",[365,366,367,368,369,370,371],"Child","Hemolytic Uremic Syndrome","Shiga-Toxigenic Escherichia coli","Renal Replacement Therapy","Acute Kidney Injury","Ambulatory Care","Emergency Department","2026-05-13",{"date":374,"type":375},"2026-05-18","ACTUAL",{"date":377,"type":375},"2022-09-29",{"date":379,"type":356},"2028-08-31",{"name":5,"class":6},26]