Hyperhydration to Improve Kidney Outcomes in Children with Shiga Toxin-Producing E. Coli Infection

Year 1: Year 1 will be devoted to study start-up. Tasks include seeking local IRB approval, advertising the study within the site’s catchment area, participating in study training, overseeing study implementation, ensuring study awareness with site stakeholders, and executing and overseeing the subcontract. Years 2-5: The recruitment period runs from Year 2 through 5. Sites will recruit 5-15 eligible patients per year from the emergency department and the broader catchment area. Tasks include determining patient eligibility, facilitating informed consent for data and biospecimen collection, abstracting data, maintaining study logs and regulatory binders, completing electronic study forms and ensuring completeness, ensuring GCP and IRB compliance, reporting adverse events in accordance with local regulatory requirements, collecting biospecimens when appropriate, conducting follow-up when required, and participating in all regulatory activities. In the winter of Year 3/4, tasks include preparing for the crossover to the new allocation arm (e.g. hospital-wide adoption of the new fluid protocol) and ensuring stakeholder familiarity with the new clinical care pathway for STEC infection. At the end of Year 5, tasks include shipping collected biospecimens to central sites for the establishment of the HIKO STEC biorepository. Year 6: Year 6 is devoted to resolving all data queries from the Data Coordinating Center and notifying the IRB of the study closure. Site Investigators may assist in data analysis and manuscript development where appropriate.