Shiga Toxin Producing Escherichia Coli (STEC) Volume Expansion

• Status: Withdrawn
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Treatments: Shiga Toxins

Criteria

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)