Status:
WITHDRAWN
Shiga Toxin Producing Escherichia Coli (STEC) Volume Expansion
Lead Sponsor:
University of Calgary
Conditions:
Hemolytic-Uremic Syndrome
Eligibility:
All Genders
6-18 years
Phase:
PHASE1
Brief 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. co...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age \<18.0 years;
- STEC infection \[positive culture OR antigen OR polymerase chain reaction test for Stx/gene\];
- 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
- Evidence of evolving HUS: A) Hematocrit \<30% OR B) Platelet count \<150 x 109/L;
- Responsible physician desires patient admission (therefore unable to randomize);
- Unable to contact family within 48 hours of positive stool test;
- Patient with history of atypical HUS;
- Chronic disease limiting fluid volumes administered (e.g. impaired cardiac function)
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03275792
Start Date
May 1 2020
End Date
April 1 2021
Last Update
November 9 2020
Active Locations (1)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8