Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection (HIKO-STEC)
Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection, Hemolytic-Uremic Syndrome
About this trial
This is an interventional treatment trial for Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection focused on measuring Child, Hemolytic Uremic Syndrome, Shiga-Toxigenic Escherichia coli, Renal Replacement Therapy, Acute Kidney Injury, Ambulatory Care, Emergency Department
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Sites / Locations
- University of Alabama at BirminghamRecruiting
- Arkansas Children's HospitalRecruiting
- University of California, San DiegoRecruiting
- University of California, DavisRecruiting
- University of Colorado DenverRecruiting
- Children's Research InstituteRecruiting
- Emory UniversityRecruiting
- Indiana University Children's HospitalRecruiting
- University of KentuckyRecruiting
- Norton Children's HospitalRecruiting
- Children's Minnesota HospitalRecruiting
- Washington UniversityRecruiting
- Children's Hospital Medical CenterRecruiting
- University Hospitals Rainbow Babies & Children's HospitalRecruiting
- Nationwide Children's HospitalRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Oregon Health & Science UniversityRecruiting
- Medical University of South CarolinaRecruiting
- Vanderbilt Children's HospitalRecruiting
- Baylor College of MedicineRecruiting
- University of UtahRecruiting
- Seattle Children's HospitalRecruiting
- Alberta Children's HospitalRecruiting
- University of AlbertaRecruiting
- McMaster UniversityRecruiting
- The Hospital for Sick ChildrenRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Hyperhydration
Conservative Fluid Management
In this study arm, all eligible children are admitted for the administration of intravenous fluids. The following specifics will form the basis of the fluid management protocol: Reversal of dehydration: Initial ED rehydration strategies should focus on rapidly reversing dehydration. Infusion of 200% of maintenance fluids x 24 hours If hematocrit reduction < 20% from initial value, repeat step #2 [infusion of 200% maintenance fluids x 24 hours]. Oral fluids permitted ad lib. Once the target hematocrit reduction is achieved (20% decrement in initial HCT) AND a 10% weight gain, adjust total IV fluid volume to maintain targeted weight gain: insensible plus output (i.e., urine plus stool).
The conservative fluid management arm has been designed to align and integrate into existing local practice patterns. Implementation of this approach will allow institutions and their practitioners to choose their management of protocol eligible children. All children will undergo a protocolized baseline evaluation that includes reversal of dehydration (if present) and follow-up plan (see Pre-Pathway care). The fluid management decision in the ED (i.e., to treat dehydration) will be at the discretion of the clinical care team. In the absence of evidence of microangiopathy (i.e., normal urinalysis, LDH, hemoglobin and platelet counts, and creatinine concentrations), the decision to admit the child to hospital or discharge the child to home will be at the discretion of the clinical care team. If microangiopathy is present (i.e., abnormal urinalysis, LDH, hemoglobin or platelet counts, or creatinine concentrations) admission for monitoring will be required.