[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"shiga-toxin-producing-escherichia-coli-e-coli-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:shiga-toxin-producing-escherichia-coli-e-coli-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"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":21,"type":22},1040,"ESTIMATED","INTERVENTIONAL",[25],"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).",[28,29],"Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection","Hemolytic-Uremic Syndrome",[31,32,33,34,35,36,37],"Child","Hemolytic Uremic Syndrome","Shiga-Toxigenic Escherichia coli","Renal Replacement Therapy","Acute Kidney Injury","Ambulatory Care","Emergency Department","RECRUITING","2026-05-13",{"date":41,"type":42},"2026-05-18","ACTUAL",{"date":44,"type":42},"2022-09-29",{"date":46,"type":22},"2028-08-31",{"name":48,"class":49},"University of Calgary","OTHER",26]