Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-21
SponsorUniversity of Calgary
About this trial
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. coli (STEC) infection in children and adolescents when compared with traditional approaches (conservative fluid management).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 9.0 months to <21 years at the time of informed consent.
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
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Infusion of 200% maintenance fluids as balanced crystalloid IV solution
Other interventionInfusion 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
Other interventionAdministration of less than or equal to 110% of maintenance fluids as oral or balanced crystalloid IV solution.
Treatment groups
1,040 Participants
are divided into 2 treatment groupsGroup A: HyperhydrationExperimental treatment 1 intervention
Group B: Conservative Fluid ManagementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Major Adverse Kidney Events by 30 days (MAKE30)
1. Death due to any cause censored at 30 days after enrollment OR 2. Provision of RRT, any modality, within 30 days of trial enrollment OR 3. Sustained loss of kidney function (100% increase of serum sCr from baseline at 30±7 days)
Time frame
30 daysSecondary outcomes
1
Number of Participants with Significant Extrarenal Complications (life-threatening):
a. Neurologic: i. Seizures requiring anticonvulsant therapy ii. Coma iii. Thrombotic or hemorrhagic stroke confirmed by neuroimaging b. Cardiac: i. Myocardial infarction ii. Myocarditis iii. Myocardial dysfunction iv. Arrhythmias requiring cardioversion or pharmacological anti-arrhythmic therapy c. Respiratory: i. Respiratory failure ii. Pleural effusions d. Gastrointestinal: i. Hyperglycemia requiring prolonged insulin therapy ii. Bowel obstruction/perforation requiring surgical repair iii. Intussusception requiring reduction iv. Acute cholecystitis v. Pancreatitis vi. Hepatitis/ liver failure vii. Ascites requiring paracentesis e. Infectious complications i. Bacteremia ii. Peritonitis
Time frame
30 days2
Number of Participants who Develop HUS among those without it at randomization
1. Anemia (hematocrit level \<30%) AND 2. Thrombocytopenia (platelet count \<150 X 103/mm3) AND 3. Renal azotemia (serum creatinine concentration \>upper limit of reference range for age)
Time frame
30 daysOther outcomes
1
Length of Stay
1. Number of days as an inpatient 2. Number of days in an intensive care unit (a unit capable of providing mechanical ventilation) 3. Hospital-Free Days: Measured as the number of calendar days alive and out of the hospital between randomization (day 0) and day 30. Patients who die prior to hospital discharge will be recorded as zero hospital-free days. 4. Score each hospital day * \# days with HUS with RRT * \# days with HUS without RRT * \# days in hospital - no HUS
Time frame
30 days2
Number of Participants who Receive Transfusion Therapy
1. Red Blood Cell 2. Platelets
Time frame
30 days3
Number of Participants who Receive Invasive Medical Procedures
1. Mechanical ventilation 2. Endotracheal intubation 3. Thoracentesis, thoracotomy, ARDS 4. Central venous catheter insertion 5. Dialysis catheter insertion 6. Therapeutic plasma exchange 7. Other operative room surgical interventions
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Calgary
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator
Washington University School of Medicine
Collaborator
University of Utah
Collaborator
Seattle Children's Hospital
Collaborator
University of Colorado, Denver
Collaborator
Emory University
Collaborator
University of California, Davis
Collaborator
Baylor College of Medicine
Collaborator
Indiana University
Collaborator
University of Alabama at Birmingham
Collaborator
Arkansas Children's Hospital Research Institute
Collaborator
Children's National Research Institute
Collaborator
Children's Hospitals and Clinics of Minnesota
Collaborator
Medical University of South Carolina
Collaborator
University of Louisville
Collaborator
University of Oklahoma
Collaborator
Oregon Health and Science University
Collaborator
University of California, San Diego
Collaborator
McMaster University
Collaborator
The Hospital for Sick Children
Collaborator
University of Alberta
Collaborator
University of Kentucky
Collaborator
Case Western Reserve University
Collaborator
Nationwide Children's Hospital
Collaborator
Vanderbilt University Medical Center
Collaborator
Source ClinicalTrials.gov