Shiga Toxin Producing Escherichia Coli (STEC) Volume Expansion
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|ClinicalTrials.gov Identifier: NCT03275792|
Recruitment Status : Withdrawn (Funding not obtained.)
First Posted : September 8, 2017
Last Update Posted : November 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hemolytic-Uremic Syndrome||Drug: D5-0.9%NS Drug: Routine home oral rehydration||Phase 1|
Background: Shiga toxin-producing Escherichia coli (STEC) cause a spectrum of disease, ranging from asymptomatic carriage to bloody diarrhea and the hemolytic uremic syndrome (HUS). HUS is caused by a toxin that destroys red blood cells, consumes platelets and impairs kidney function. HUS results in morbidity and even death in otherwise healthy children. Over the last 30 years however, there has been extremely limited progress in preventing acute and long-term complications in children with STEC infection. However, it is believed that Shiga toxins generate clots or blockages in the kidneys that damage it much the way strokes cause brain damage. There is emerging evidence that if children with STEC infection are recognized early, then the interval between diarrhea onset and the presence of HUS could be exploited to preserve kidney function through the use of intravenous rehydration.
Study Design: The investigators propose to conduct the first randomized clinical trial of volume expansion therapy in children with STEC infection. Employing Alberta's unique province-wide microbiology network and its only two pediatric tertiary care centres, the investigators will conduct a proof of principal feasibility study that evaluates novel technologies to identify STEC infected children and those at risk for HUS.
Objectives: The primary outcome will be process: number of children recruited. Secondary outcomes will include: 1) resources: retention; refusal; compliance; eligibility criteria; questionnaires; data collection tools; and time requirements; 2) management: capacity and impact on clinical services; 3) scientific: utility of point-of-care STEC diagnostics; use of urine biomarkers to identify high risk children, monitoring of kidney injury and response to therapy; and safety.
Significance: This pilot will provide the necessary data to integrate novel technologies into the design and conduct of a multicentre, multinational, clinical trial that will reduce morbidity and mortality from STEC infection.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Inpatient Volume Expansion in Children With Shiga Toxin-Producing Escherichia Coli (STEC) Infection to Prevent Hemolytic Uremic Syndrome (HUS)|
|Estimated Study Start Date :||May 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: Admission/Intravascular Volume Expansion
Admission for intravascular volume expansion
Active Comparator: Outpatient Observation
Drug: Routine home oral rehydration
Routine oral fluids as is given at home to all children with acute diarrheal disease
- Number of children enrolled in the study protocol [ Time Frame: at the end of the 24 month study recruiting period ]The number of children recruited per month per site will be calculated and will be related to the number screened, number eligible, and number consented.
- The proportion of children enrolled in each study arm who develop adverse events [ Time Frame: at the end of the 24 month study recruiting period ]For participants enrolled in each study arm we will quantify the proportion that are admitted to Intensive Care Units, the proportion requiring respiratory support (CPAP, BiPAP, endotracheal intubation), hypoxia defined by the administration of supplemental oxygen, and evidence of congestive heart failure defined by blinded independent reviewers.
- Retention [ Time Frame: at the end of the 24 month study recruiting period ]The proportion of children who complete the study protocol
- Time requirements [ Time Frame: at the end of the 24 month study recruiting period ]We will quantify the number of hours children remain admitted and to which clinical units
- Child/family perspectives [ Time Frame: at the end of the 24 month study recruiting period ]7-item likert scales will be employed to evaluate perspectives of parents and participants as appropriate related to study protocols, procedures and participation
- compliance/adherence [ Time Frame: at the end of the 24 month study recruiting period ]The proportion of children enrolled in each study arm who comply with the key interventions of the respective study arms
- data collection tool performance [ Time Frame: at the end of the 24 month study recruiting period ]Individual data fields will be audited with respect to data quality, reliability, completeness, timeliness of completion
- Impact on clinical services [ Time Frame: at the end of the 24 month study recruiting period ]We will qualitatively explore with the department leads at the respective institutions if the study protocol had any impact on clinical care provided either to the admitted patients or to other patients on their services
- Cost [ Time Frame: at the end of the 24 month study recruiting period ]We will quantify the costs per child in each study arm
- Point-of-Care STEC diagnosis [ Time Frame: at the end of the 24 month study recruiting period ]diagnostic accuracy compared with standard culture
- Urine biomarkers [ Time Frame: at the end of the 24 month study recruiting period ]ability to predict progression to AKI and HUS
- Point-of-Care STEC diagnosis [ Time Frame: at the end of the 24 month study recruiting period ]turnaround time
- Point-of-Care STEC diagnosis [ Time Frame: at the end of the 24 month study recruiting period ]proportion O157 vs other STEC
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275792
|Alberta Children's Hospital|
|Calgary, Alberta, Canada, T3B 6A8|
|Principal Investigator:||Stephen Freedman, MDCM, MSc||University of Calgary|