Comparing Infusion of with Oral fluids; for shiga toxin-producing escherichia coli (e. coli) infection
Official title: Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
Hyperhydration to Improve Kidney Outcomes in Children With Shiga Toxin-Producing E. Coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial
- 2 groups
- Sites in Calgary, Edmonton and 2 more cities
- Recruiting
Interventions
- Other intervention
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.
- Other intervention
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.
Canadian Sites (4)
4 of 4 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta
- Recruiting
University of Alberta
Edmonton, Alberta
- Recruiting
McMaster University
Hamilton, Ontario
- Recruiting
The Hospital for Sick Children
Toronto, Ontario
Eligibility Criteria
See who this study is looking for26 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +In order to be eligible to participate in this study (i.e., to be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → 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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +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 criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → at baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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 or caregivers with language barriers impairing appropriate conduct of the study protocolProtocolThe detailed plan a study must follow.Read more →.
- −Patients with known pregnancy
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Infusion of 200% maintenance fluids as balanced crystalloid IV solution.
Registry label: A: Hyperhydration
Group B, the comparison group, receives Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution.
Registry label: B: Conservative Fluid Management
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 9 months to 21 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,040 people.
The study is currently expected to finish around August 2028.
The main measurement is taken over: 30 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Major Adverse Kidney Events by 30 days (MAKE30) — measured over 30 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05219110 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Infusion of 200% maintenance fluids as balanced crystalloid IV solutionOther
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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solutionOther
Administration of less than or equal to 110% of maintenance fluids as oral or balanced crystalloid IV solution.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 9 months to 21 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 9 months to 21 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 30 days.
The study as a whole is currently expected to finish around 2028-08-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,040 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Hamilton, Ontario, Canada; Toronto, Ontario, Canada; Minneapolis, Minnesota, United States; Seattle, Washington, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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).
Other Sites (2)
Children's Minnesota Hospital
Minneapolis, Minnesota, United States
Seattle Children's Hospital
Seattle, Washington, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.