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.
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 randomized controlled trial (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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
112
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.
Mount Sinai Hospital Department of Emergency Medicine
New York, New York, United States
Type of Re-hydration
Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED)
Time frame: Day 1
Vascular Access Point
For sepsis arm, Secured second vascular access point- type (Interosseous (IO), second Intravenous (IV), central venous (CV) access) within 15 min of physician evaluation
Time frame: Day 1
Antibiotic Use
For sepsis arm, antibiotic given within 60 min
Time frame: 60 minutes
Normal Saline Bolus
For sepsis arm, 60 ml/kg Normal Saline bolus administered within 60 minutes
Time frame: 60 minutes
Disposition Status
Pediatric Intensive Care Unit (PICU), Floor, Discharge
Time frame: Day 1
Length of ED Stay (From Sepsis Alert to Admission/Discharge Order Entry)
Time frame: 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
Time frame: 48 hours
Survival to Hospital Discharge
For sepsis arm, at time of emergency department or hospital discharge
Time frame: 30 days
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30 Day Mortality
Assessed any time after 30 days from emergency department registration date.
Time frame: 30 days
Left Ventricular Function
For sepsis arm, during emergency department visit
Time frame: Day 1
Source of Sepsis
For sepsis arm, during emergency department or hospital visit
Time frame: Day 1