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Could more water save Kids' kidneys? new trial tests simple IV strategy

NCT ID NCT05219110

Disease control Sponsor: University of Calgary Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving children with a severe E. coli infection extra fluids through an IV can prevent kidney failure. About 1,040 children aged 9 months to 21 years will take part. The goal is to see if this simple approach reduces the need for dialysis or long-term kidney damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intravenous fluids (balanced crystalloid solution)
What this could lead to
If it works, this simple fluid strategy could prevent severe kidney damage and reduce the need for dialysis in children with E. coli infection.
What could go wrong
This is an early-stage trial with no phase designation, and the benefit of hyperhydration is unproven. There is a risk of fluid overload or electrolyte imbalances.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,040 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

9 months to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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: All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation. 1. Presence of Advanced HUS defined by: 1. Hematocrit \<30% AND 2. Platelet count \<150 x 103/mm3 AND 3. 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. 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.

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Conditions

The condition(s) this trial relates to.

acute kidney injury Emergencies escherichia coli infection hemolytic-uremic syndrome Infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemolytic-uremic syndrome Shiga toxin-producing escherichia coli (E. coli) infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alberta Children's Hospital

    RECRUITING

    Calgary, Alberta, T2N 1N4, Canada

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229-3039, United States

  • Children's Minnesota Hospital

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Children's Research Institute

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Indiana University Children's Hospital

    RECRUITING

    Indianapolis, Indiana, 47401, United States

  • McMaster University

    RECRUITING

    Hamilton, Ontario, L8S 4K1, Canada

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Norton Children's Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • The Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • University Hospitals Rainbow Babies & Children's Hospital

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Alberta

    RECRUITING

    Edmonton, Alberta, T5J 4P6, Canada

  • University of California, Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • University of California, San Diego

    RECRUITING

    La Jolla, California, 92093, United States

  • University of Colorado Denver

    RECRUITING

    Denver, Colorado, 80045, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40526, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Vanderbilt Children's Hospital

    RECRUITING

    Nashville, Tennessee, 43205, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

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