Status:
RECRUITING
Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Children's Hospital Medical Center, Cincinnati
Conditions:
Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection
Hemolytic-Uremic Syndrome
Eligibility:
All Genders
9-21 years
Phase:
NA
Brief Summary
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...
Detailed Description
The hemolytic uremic syndrome (HUS) is the most serious complication of high-risk Shiga toxin-producing Escherichia coli (STEC) infection and the most common cause of acquired acute kidney injury in o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Presence of Advanced HUS defined by:
- Hematocrit \<30% AND
- Platelet count \<150 x 103/mm3 AND
- Creatinine \> 2.0 mg/dL (177 µmol/L)
- The presence of only 1 or 2 of these criteria will not result in patient exclusion, regardless of how close the 3rd criterion is to meeting the exclusion criteria.
- Prior episode of HUS or diagnosis of atypical HUS.
- Chronic disease limiting fluid volumes administered (e.g. impaired renal, liver, or cardiac function, chronic lung disease).
- Evidence of anuria (i.e., no urine output for \> 24 hours).
- Hypoxemia requiring oxygen therapy
- Hypertensive emergency
- Greater than or equal to 10 days since onset of diarrhea or if no diarrhea then the onset of other symptoms.
- Patients with known pregnancy
- Patients or caregivers with language barriers impairing appropriate conduct of the study protocol.
Key Trial Info
Start Date :
September 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
1040 Patients enrolled
Trial Details
Trial ID
NCT05219110
Start Date
September 29 2022
End Date
August 31 2027
Last Update
June 5 2025
Active Locations (26)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
University of California, San Diego
La Jolla, California, United States, 92093
4
University of California, Davis
Sacramento, California, United States, 95817