Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
NCT ID: NCT05219110
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1040 participants
INTERVENTIONAL
2022-09-29
2027-08-31
Brief Summary
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Detailed Description
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Recent cohort studies suggest that early intravascular volume expansion (hyperhydration) in STEC infected children could be nephroprotective if and when HUS occurs. However, more evidence is needed before hyperhydration supplants traditional 'wait and see' (i.e., conservative fluid management) reactive care approaches which focus on outpatient care and minimizing intravenous fluid administration to avoid fluid overload in children who do develop HUS. Here, we will confirm or refute the hypothesis that aggressive volume expansion, administered early in STEC infected children, is associated with better renal outcomes and fewer adverse events than conservative management by accomplishing three Specific Aims: (1) Determine the effectiveness of hyperhydration in decreasing the prevalence of Major Adverse Kidney Events by 30 days (defined as death, RRT, or sustained loss of kidney function at 30 days) in STEC-infected children versus conservative fluid management; (2) Determine the effectiveness and safety of hyperhydration in decreasing HUS and life-threatening, extrarenal complications in STEC-infected children versus conservative fluid management; (3) Create a biorepository that will be linked to our clinical data to identify prognostic biomarkers and therapeutic targets in STEC-infected children.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Hyperhydration
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:
1. Reversal of dehydration: Initial ED rehydration strategies should focus on rapidly reversing dehydration.
2. Infusion of 200% of maintenance fluids x 24 hours
3. If hematocrit reduction \< 20% from initial value, repeat step #2 \[infusion of 200% maintenance fluids x 24 hours\].
4. Oral fluids permitted ad lib.
5. 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).
Infusion of 200% maintenance fluids as balanced crystalloid IV solution
Infusion of 200% of maintenance fluids x 24 hours provided, ideally, as a balanced crystalloid (PlasmaLyteTM, Ringer's Lactate) IV solution. Electrolytes and dextrose may be administered as required and desired by the clinical care team; customized solutions are permitted if so desired. Intravenous fluid solutions containing \< 130 mEq/L sodium may increase risk for hyponatremia and may be less effective in achieving intravascular volume expansion and should be avoided.
Conservative Fluid Management
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.
Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution
Administration of less than or equal to 110% of maintenance fluids as oral or balanced crystalloid IV solution.
Interventions
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Infusion of 200% maintenance fluids as balanced crystalloid IV solution
Infusion of 200% of maintenance fluids x 24 hours provided, ideally, as a balanced crystalloid (PlasmaLyteTM, Ringer's Lactate) IV solution. Electrolytes and dextrose may be administered as required and desired by the clinical care team; customized solutions are permitted if so desired. Intravenous fluid solutions containing \< 130 mEq/L sodium may increase risk for hyponatremia and may be less effective in achieving intravascular volume expansion and should be avoided.
Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution
Administration of less than or equal to 110% of maintenance fluids as oral or balanced crystalloid IV solution.
Eligibility Criteria
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Inclusion Criteria
1. Aged 9.0 months to \<21 years at the time of informed consent.
2. Evidence of high-risk STEC infecting pathogen defined by any of the following:
1. 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
2. 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
3. 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
1. Hematocrit \<30% AND
2. Platelet count \<150 x 103/mm3 AND
3. Creatinine \> 2.0 mg/dL (177 µmol/L)
2. Prior episode of HUS or diagnosis of atypical HUS.
3. Chronic disease limiting fluid volumes administered (e.g. impaired renal, liver, or cardiac function, chronic lung disease).
4. Evidence of anuria (i.e., no urine output for \> 24 hours).
5. Hypoxemia requiring oxygen therapy
6. Hypertensive emergency
7. Greater than or equal to 10 days since onset of diarrhea or if no diarrhea then the onset of other symptoms.
8. Patients with known pregnancy
9. Patients or caregivers with language barriers impairing appropriate conduct of the study protocol.
9 Months
21 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER
Washington University School of Medicine
OTHER
University of Utah
OTHER
Seattle Children's Hospital
OTHER
University of Colorado, Denver
OTHER
Emory University
OTHER
University of California, Davis
OTHER
Baylor College of Medicine
OTHER
Indiana University School of Medicine
OTHER
University of Alabama at Birmingham
OTHER
Arkansas Children's Hospital Research Institute
OTHER
Children's National Research Institute
OTHER
Children's Hospitals and Clinics of Minnesota
OTHER
Medical University of South Carolina
OTHER
University of Louisville
OTHER
University of Oklahoma
OTHER
Oregon Health and Science University
OTHER
University of California, San Diego
OTHER
McMaster University
OTHER
The Hospital for Sick Children
OTHER
University of Alberta
OTHER
University of Kentucky
OTHER
Case Western Reserve University
OTHER
Nationwide Children's Hospital
OTHER
Vanderbilt University Medical Center
OTHER
University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Stephen Freedman, MDCM
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
University of California, San Diego
La Jolla, California, United States
University of California, Davis
Sacramento, California, United States
University of Colorado Denver
Denver, Colorado, United States
Children's Research Institute
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Indiana University Children's Hospital
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Children's Minnesota Hospital
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Children's Hospital Medical Center
Cincinnati, Ohio, United States
University Hospitals Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
McMaster University
Hamilton, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Central Contacts
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References
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Imdad A, Nelson JR, Tanner-Smith EE, Huang D, Gomez-Duarte OG. Interventions for preventing diarrhoea-associated haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2025 Apr 25;4(4):CD012997. doi: 10.1002/14651858.CD012997.pub3.
Freedman SB, Schnadower D, Estes M, Casper TC, Goldstein SL, Grisaru S, Pavia AT, Wilfond BS, Metheney M, Kimball K, Tarr PI; Hyperhydration to Improve Kidney Outcomes in children with Shiga Toxin-producing E. Coli infection (HIKO-STEC) Study Team. Hyperhydration to Improve Kidney Outcomes in Children with Shiga Toxin-Producing E. coli Infection: a multinational embedded cluster crossover randomized trial (the HIKO STEC trial). Trials. 2023 May 27;24(1):359. doi: 10.1186/s13063-023-07379-w.
Other Identifiers
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DMID 21-0042
Identifier Type: -
Identifier Source: org_study_id
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