Shiga Toxin Producing Escherichia Coli (STEC) Volume Expansion
Shiga Toxin Producing Escherichia Coli (STEC) Volume Expansion
This study will provide feasibility data regarding the conduct of a clinical trail evaluating
 the use of early aggressive inpatient intravenous rehydration in children with Shiga Toxin
 producing E. coli infection.
Background: Shiga toxin-producing Escherichia coli (STEC) cause a spectrum of disease,
 ranging from asymptomatic carriage to bloody diarrhea and the hemolytic uremic syndrome
 (HUS). HUS is caused by a toxin that destroys red blood cells, consumes platelets and impairs
 kidney function. HUS results in morbidity and even death in otherwise healthy children. Over
 the last 30 years however, there has been extremely limited progress in preventing acute and
 long-term complications in children with STEC infection. However, it is believed that Shiga
 toxins generate clots or blockages in the kidneys that damage it much the way strokes cause
 brain damage. There is emerging evidence that if children with STEC infection are recognized
 early, then the interval between diarrhea onset and the presence of HUS could be exploited to
 preserve kidney function through the use of intravenous rehydration.

 Study Design: The investigators propose to conduct the first randomized clinical trial of
 volume expansion therapy in children with STEC infection. Employing Alberta's unique
 province-wide microbiology network and its only two pediatric tertiary care centres, the
 investigators will conduct a proof of principal feasibility study that evaluates novel
 technologies to identify STEC infected children and those at risk for HUS.

 Objectives: The primary outcome will be process: number of children recruited. Secondary
 outcomes will include: 1) resources: retention; refusal; compliance; eligibility criteria;
 questionnaires; data collection tools; and time requirements; 2) management: capacity and
 impact on clinical services; 3) scientific: utility of point-of-care STEC diagnostics; use of
 urine biomarkers to identify high risk children, monitoring of kidney injury and response to
 therapy; and safety.

 Significance: This pilot will provide the necessary data to integrate novel technologies into
 the design and conduct of a multicentre, multinational, clinical trial that will reduce
 morbidity and mortality from STEC infection.
Inclusion Criteria:

 1. Age <18.0 years;

 2. STEC infection [positive culture OR antigen OR polymerase chain reaction test for
 Stx/gene];

 3. Day of illness 1-10: Children who develop HUS will do so by day #14 of illness;8
 restricting enrolment to the first 10 days will ensure all participants are at risk of
 HUS.

 Exclusion Criteria:

 1. Evidence of evolving HUS: A) Hematocrit <30% OR B) Platelet count <150 x 109/L;

 2. Responsible physician desires patient admission (therefore unable to randomize);

 3. Unable to contact family within 48 hours of positive stool test;

 4. Patient with history of atypical HUS;

 5. Chronic disease limiting fluid volumes administered (e.g. impaired cardiac function)