Hyperhydration to Improve Kidney Outcomes in Children With Shiga Toxin-Producing E. Coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial
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).
⁃ In 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:
• Aged 9.0 months to \<21 years at the time of informed consent.
• Evidence of high-risk STEC infecting pathogen defined by any of the following:
‣ Bloody diarrhea within the preceding 7 days
• Positive STEC culture OR
∙ Positive antigen/polymerase chain reaction test for toxin/gene type not otherwise specified OR
⁃ Bloody or Non-bloody diarrhea within the preceding 7 days
‣ •Presumptive diagnosis of HUS
∙ (meeting all 3 HUS criteria - anemia, thrombocytopenia, and renal insufficiency) OR
⁃ Non-bloody or no diarrhea
• Positive STEC culture for high-risk strain (i.e., O103, O104, O111, O113, O121, O145 or O157) OR
∙ Positive antigen/polymerase chain reaction test Stx2 toxin/gene