Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration

Study Overview
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Brief Summary
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Conduct a randomized, controlled trial looking at how the use of ultrasound analyzing the inferior vena cava impacts the management and outcomes of pediatric emergency department patients undergoing evaluation and treatment of sepsis and gastroenteritis associated dehydration.

Detailed Description
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Ultrasound is a widely accepted and highly useful clinical tool. It carries the additional advantage of being rapid, painless and non-radiating. It has long been used to assess cardiac output and vascular pathologies. More recently emergency and trauma clinicians have been using it to assess hydration status, shock/sepsis states and fluid responsiveness. Using sonography to look at the inferior vena cava gives clinician a rapid view of vascular collapsibility that has been previously demonstrated to correlate with mean arterial pressure (MAP) and central venous pressure (CVP). Previously, Jones et. al. completed an RCT in adults greater than age 17 evaluating the goal directed utility of early versus delayed inferior vena cava sonography for patients presenting with non traumatic hypotension to the emergency department. This study found improved outcomes and more accuracy in diagnostic etiology in those undergoing immediate IVC imaging. The study conducts a randomized controlled trial of IVC Ultrasonography in pediatric patients 0-21 year of age. Patients admitted to the Emergency Department and triggering triage STOP SEPSIS ALERT (based on triage vital signs and chief complaint), vomiting requiring zofran or diarrhea with concern for dehydration/hypovolemia, the treating physician believes would benefit from intravenous fluids, will be eligible for inclusion into this study. The treating physician refers to one of the Pediatric Emergency Medicine attendings or fellows, listed as co-investigators. Only if and when a patient or parent expresses interest in participating in the study, the attending or fellow caring for the patient will determine if the patient is eligible. If the patient is eligible, and has no criteria that would exclude them from the study, written informed consent will be obtained from the guardian and assent will be obtained in children > 7 years old. The patient will be enrolled in the study and randomized to either the immediate ultrasonography group (Ultrasound (US) of the Inferior Vena Cava (IVC) first before the clinician fully assesses the patient and places rehydration orders) or the control group (US at 15 minutes into the assessment and management of the patient). The goal will be to assess how the use of ultrasound impacts clinical management and outcomes in patients presenting to the pediatric emergency department with sepsis and dehydration.

Official Title
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Randomized Controlled Trial of Inferior Vena Cava Ultrasonography in the Management and Disposition of Pediatric Patients Undergoing Evaluation for Sepsis and Dehydration

Conditions
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Sepsis, Gastroenteritis, Dehydration

Intervention / Treatment
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* Device: SonoSite Maxx Series Ultrasound System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trigger triage STOP SEPSIS ALERT (based on triage vital signs and chief complaint) Present with vomiting requiring Zofran Present with diarrhea with concern for dehydration/hypovolemia Exclusion Criteria: Unstable patients with life-threatening injuries who require ongoing resuscitation Patient undergoing traumatic resuscitation

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sepsis 1<br>Sepsis patients receiving SonoSite Maxx Series Ultrasound System ultrasound prior to clinical orders including medication and fluid orders being placed by the treating physician | Device: SonoSite Maxx Series Ultrasound System<br>* Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.<br>|
| Active Comparator: Sepsis 2<br>Sepsis patients having SonoSite Maxx Series Ultrasound System ultrasound performed after clinical orders have been placed by the treating physician | Device: SonoSite Maxx Series Ultrasound System<br>* Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.<br>|
| Experimental: Gastroenteritis 1<br>Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician | Device: SonoSite Maxx Series Ultrasound System<br>* Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.<br>|
| Active Comparator: Gastroenteritis 2<br>Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician | Device: SonoSite Maxx Series Ultrasound System<br>* Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of re-hydration | Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED) | Day 1 | 
| Vascular access point | Secured second vascular access point- type (Interosseous (IO), second Intravenous (IV), central venous (CV) access) within 15 min of physician evaluation | Day 1 | 
| Antibiotic use | Antibiotic given within 60 min | 60 minutes | 
| Normal Saline bolus | 60 ml/kg Normal Saline bolus administered within 60 minutes | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disposition Status | Pediatric Intensive Care Unit (PICU), Floor, Discharge | Day 1 | 
| Length of ED stay (from sepsis alert to admission/discharge order entry) |  | Time between emergency department registration and disposition (admit, transfer or discharge) | 
| Return ED Visit for same illness within 48 hours | At greater than 48 hours post emergency department disposition | 48 hours | 
| Survival to hospital discharge | At time of emergency department or hospital discharge | 30 days | 
| 30 day mortality | Assessed any time after 30 days from emergency department registration date. | 30 days | 
| Left ventricular function | During emergency department visit | Day 1 | 
| Source of sepsis | During emergency department or hospital visit | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Gastroenteritis, Dehydration, Ultrasound, Ultrasonography, Inferior Vena Cava