Shiga Toxin-Producing Escherichia Coli (E. Coli) InfectionHIKO-STECNCT05219110
Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
A study testing Infusion of 200% maintenance fluids as balanced crystalloid IV solution and Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution in people with Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection and Hemolytic-Uremic Syndrome, run by University of Calgary at 26 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 months to 21 years
- Conditions the study is for
- Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection, Hemolytic-Uremic Syndrome
- What is being tested?
- Infusion of 200% maintenance fluids as balanced crystalloid IV solution and Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 29 Sep 2022to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
26 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 2 countries
United States22 sites, 22 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
- Recruiting
University Hospitals Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
- Recruiting
University of Colorado Denver
Denver, Colorado, 80045
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
- Recruiting
Indiana University Children's Hospital
Indianapolis, Indiana, 47401
- Recruiting
University of California, San Diego
La Jolla, California, 92093
- Recruiting
University of Kentucky
Lexington, Kentucky, 40526
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
- Recruiting
Norton Children's Hospital
Louisville, Kentucky, 40202
- Recruiting
Children's Minnesota Hospital
Minneapolis, Minnesota, 55404
- Recruiting
Vanderbilt Children's Hospital
Nashville, Tennessee, 43205
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
- Recruiting
University of California, Davis
Sacramento, California, 95817
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
- Recruiting
Washington University
St Louis, Missouri, 63110
- Recruiting
Children's Research Institute
Washington D.C., District of Columbia, 20010
Canada4 sites, 4 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T2N 1N4
- Recruiting
University of Alberta
Edmonton, Alberta, T5J 4P6
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4K1
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: Hyperhydration to Improve Kidney Outcomes in Children With Shiga Toxin-Producing E. Coli Infection: A Multinational Embedded Cluster Crossover Randomized 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).
Read the detailed description
The hemolytic uremic syndrome (HUS) is the most serious complication of high-risk Shiga toxin-producing Escherichia coli (STEC) infection and the most common cause of acquired acute kidney injury in otherwise healthy children. HUS develops in up to 20% of children following STEC infection, 60% of whom require temporary renal replacement therapy (RRT); an additional 50% develop serious extrarenal complications. Although mortality from acute HUS is low (1-3%), it has remained constant for three decades and approximately 30% of HUS survivors experience long-term sequelae, chiefly chronic kidney disease, hypertension, and diabetes. There have been only three relatively small, randomized trials to prevent progression to HUS and/or to reduce kidney injury once HUS is established; none have demonstrated benefits, and none have been performed since 1999.
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.
- Being tested
- Infusion of 200% maintenance fluids as balanced crystalloid IV solution, Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution
- Keywords
- Child, Hemolytic Uremic Syndrome, Shiga-Toxigenic Escherichia coli, Renal Replacement Therapy, Acute Kidney Injury, Ambulatory Care, Emergency Department
- Medical subject headings
- Escherichia coli Infections, Infections, Hemolytic-Uremic Syndrome, Acute Kidney Injury, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Hyperhydration | Experimental | 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). Receives: Other: Infusion of 200% maintenance fluids as balanced crystalloid IV solution |
| Conservative Fluid Management | Active comparator | 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. Receives: Other: Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Kidney Events by 30 days (MAKE30)
- Death due to any cause censored at 30 days after enrollment OR
- Provision of RRT, any modality, within 30 days of trial enrollment OR
- Sustained loss of kidney function (100% increase of serum sCr from baseline at 30±7 days)
Measured: 30 days
Secondary outcomes (2)
Number of Participants with Significant Extrarenal Complications (life-threatening):
- 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
Measured: 30 days
Number of Participants who Develop HUS among those without it at randomization
- Anemia (hematocrit level <30%) AND
- Thrombocytopenia (platelet count <150 X 103/mm3) AND
- Renal azotemia (serum creatinine concentration >upper limit of reference range for age)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start29 Sep 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shiga Toxin-Producing Escherichia Coli (E. Coli) InfectionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster crossover
- Masking
- None (open label)
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Children's Hospital Medical Center, Cincinnati, Washington University School of Medicine, University of Utah, Seattle Children's Hospital, University of Colorado, Denver, Emory University, University of California, Davis, Baylor College of Medicine, Indiana University, University of Alabama at Birmingham, Arkansas Children's Hospital Research Institute, Children's National Research Institute, Children's Hospitals and Clinics of Minnesota, Medical University of South Carolina, University of Louisville, University of Oklahoma, Oregon Health and Science University, University of California, San Diego, McMaster University, The Hospital for Sick Children, University of Alberta, University of Kentucky, Case Western Reserve University, Nationwide Children's Hospital, Vanderbilt University Medical Center
- Responsible party
- Sponsor
- Investigators
- Stephen Freedman, MDCM, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219110
- Sponsor's protocol ID
- DMID 21-0042
- Other IDs
- R01AI165327
- Acronym
- HIKO-STEC
- Status last verified
- May 2026
- First submitted
- 20 Jan 2022
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40277027Freedman 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.
PubMed 37245030
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperhydration to Improve Kidney Outcomes in Children With Shiga Toxin-Producing E. Coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial
- ClinicalTrials.gov ID
- NCT05219110
- Acronym / sponsor ID
- HIKO-STEC / DMID 21-0042
- Keywords
- Child, Hemolytic Uremic Syndrome, Shiga-Toxigenic Escherichia coli, Renal Replacement Therapy, Acute Kidney Injury, Ambulatory Care, Emergency Department
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Children's Hospital Medical Center, Cincinnati, Washington University School of Medicine, University of Utah, Seattle Children's Hospital, University of Colorado, Denver, Emory University, University of California, Davis, Baylor College of Medicine, Indiana University, University of Alabama at Birmingham, Arkansas Children's Hospital Research Institute, Children's National Research Institute, Children's Hospitals and Clinics of Minnesota, Medical University of South Carolina, University of Louisville, University of Oklahoma, Oregon Health and Science University, University of California, San Diego, McMaster University, The Hospital for Sick Children, University of Alberta, University of Kentucky, Case Western Reserve University, Nationwide Children's Hospital, Vanderbilt University Medical Center
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The hemolytic uremic syndrome (HUS) is the most serious complication of high-risk Shiga toxin-producing Escherichia coli (STEC) infection and the most common cause of acquired acute kidney injury in otherwise healthy children. HUS develops in up to 20% of children following STEC infection, 60% of whom require temporary renal replacement therapy (RRT); an additional 50% develop serious extrarenal complications. Although mortality from acute HUS is low (1-3%), it has remained constant for three decades and approximately 30% of HUS survivors experience long-term sequelae, chiefly chronic kidney disease, hypertension, and diabetes. There have been only three relatively small, randomized trials to prevent progression to HUS and/or to reduce kidney injury once HUS is established; none have demonstrated benefits, and none have been performed since 1999.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster crossover
| Arm | Type | Receives |
|---|---|---|
| Hyperhydration | Experimental | Other: Infusion of 200% maintenance fluids as balanced crystalloid IV solutionIn 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). |
| Conservative Fluid Management | Active comparator | Other: Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solutionThe 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. |
Who may qualify
- Ages
- 9 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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:
- •Presumptive diagnosis of HUS
Key exclusion criteria (14 listed)
- All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Presence of Advanced HUS defined by:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infusion of 200% maintenance fluids as balanced crystalloid IV solutionInfusion 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 | Hyperhydration |
| Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solutionAdministration of less than or equal to 110% of maintenance fluids as oral or balanced crystalloid IV solution. | Other | Conservative Fluid Management |
Primary outcome
Major Adverse Kidney Events by 30 days (MAKE30)
Time frame: 30 days
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)
2 secondary outcomes
Number of Participants with Significant Extrarenal Complications (life-threatening):
Time frame: 30 days
Number of Participants who Develop HUS among those without it at randomization
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 40277027Imdad 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.
- Derived from this study: PubMed 37245030Freedman 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Freedman, MDCM principal investigator
University of Calgary
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infusion of 200% maintenance fluids as balanced crystalloid IV solution and Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution in people with Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection and Hemolytic-Uremic Syndrome, run by University of Calgary at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Manager ((801) 581-6410, hikostec@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Kidney Events by 30 days (MAKE30) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05219110, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.