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Hyperhydration for E. coli Infections (HIKO-STEC Trial)

Phase 3
Recruiting
Led By Stephen Freedman, MDCM
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of high-risk STEC infecting pathogen as defined by specific criteria related to bloody or non-bloody diarrhea, presumptive diagnosis of HUS, and positive STEC culture or antigen/polymerase chain reaction test
Aged 9.0 months to <21 years at the time of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

HIKO-STEC Trial Summary

This trial will test if early, high volume fluid administration can prevent complications from STEC infection in children and adolescents.

Who is the study for?
This trial is for children and adolescents aged 9 months to under 21 years with a high-risk strain of E. coli infection that may lead to Hemolytic Uremic Syndrome (HUS). They must have symptoms like diarrhea or anemia, low platelet count, and kidney issues. It's not for those who are pregnant, have chronic diseases affecting fluid intake, started showing symptoms over 10 days ago, need oxygen therapy due to low blood oxygen levels, haven't urinated in over 24 hours, had HUS before or have severe HUS.Check my eligibility
What is being tested?
The study tests if giving lots of IV fluids early on (hyperhydration) can help kids with serious E. coli infections better than the usual amount of fluids. One group gets double the normal fluid rate through an IV; another gets up to just a bit more than normal plus oral fluids.See study design
What are the potential side effects?
Potential side effects might include water intoxication which can cause headache, vomiting, confusion or seizures due to too much fluid in the body. The exact side effects will depend on how each child's body responds to the extra fluids.

HIKO-STEC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a severe E. coli infection confirmed by tests.
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I am between 9 months and 21 years old.
Select...
I tested positive for a dangerous E. coli strain.
Select...
I have been diagnosed with HUS, showing signs of anemia, low platelet count, and kidney issues.

HIKO-STEC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Major Adverse Kidney Events by 30 days (MAKE30)
Secondary outcome measures
Number of Participants who Develop HUS among those without it at randomization
Number of Participants with Significant Extrarenal Complications (life-threatening)
Other outcome measures
Length of Stay
Number of Participants who Receive Invasive Medical Procedures
Number of Participants who Receive Transfusion Therapy

HIKO-STEC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HyperhydrationExperimental Treatment1 Intervention
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: Reversal of dehydration: Initial ED rehydration strategies should focus on rapidly reversing dehydration. Infusion of 200% of maintenance fluids x 24 hours If hematocrit reduction < 20% from initial value, repeat step #2 [infusion of 200% maintenance fluids x 24 hours]. Oral fluids permitted ad lib. 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).
Group II: Conservative Fluid ManagementActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineOTHER
1,001 Previous Clinical Trials
6,001,212 Total Patients Enrolled
Indiana University School of MedicineOTHER
185 Previous Clinical Trials
141,753 Total Patients Enrolled
Washington University School of MedicineOTHER
1,935 Previous Clinical Trials
2,298,833 Total Patients Enrolled

Media Library

Infusion of 200% maintenance fluids as balanced crystalloid IV solution Clinical Trial Eligibility Overview. Trial Name: NCT05219110 — Phase 3
E. coli Infections Research Study Groups: Hyperhydration, Conservative Fluid Management
E. coli Infections Clinical Trial 2023: Infusion of 200% maintenance fluids as balanced crystalloid IV solution Highlights & Side Effects. Trial Name: NCT05219110 — Phase 3
Infusion of 200% maintenance fluids as balanced crystalloid IV solution 2023 Treatment Timeline for Medical Study. Trial Name: NCT05219110 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current vacancies for this clinical trial?

"Based on the information available from clinicaltrials.gov, it seems that this study is currently looking for patients to enroll. This particular trial was first posted on 9/19/2022 and has been edited as recently as 9/19/2022. 26 different locations are participating in this research, with a goal of 1040 enrollees in total."

Answered by AI

What are the risks associated with a 200% maintenance fluids Infusion as balanced crystalloid IV solution for patients?

"There is some efficacy data and multiple safety rounds of Phase 3 trial, which supports a score of 3 for the Infusion of 200% maintenance fluids as balanced crystalloid IV solution."

Answered by AI

How many people are eligible for this research project?

"In order for this study to move forward, 1040 patients who fit the pre-determined inclusion criteria must enroll. These individuals can come from different parts of the country, such as Arkansas Children's Hospital in Little Rock, Arkansas and University of California, San Diego in La Jolla, California."

Answered by AI

Does this research include elderly subject matter?

"Eligibility for this study is limited to children aged 9 months to 21 years old."

Answered by AI

Do we have more than one site running this research in our region?

"Enrollment for this study is happening at 26 different locations which can be found in cities such as Little Rock, La Jolla and Birmingham. Others include _______(26 other locations). To make participation more convenient, please try to enroll at a site close to your home."

Answered by AI

Who would be an ideal candidate to participate in this research?

"The only way to be eligible for this clinical trial is by having hemolytic-uremic syndrome and being within the specified age range. This study is recruiting up to 1040 patients in total."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
2022. "Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05219110.
~620 spots leftby Aug 2026
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