Randomized Controlled Trial of Inferior Vena Cava Ultrasonography in the Management and Disposition of Pediatric Patients Undergoing Evaluation for Sepsis and Dehydration
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Vascular Access Point
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
James W Tsung MD MPH
Associate Professor
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
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
Outcomes
Primary Outcomes
Vascular Access Point
Time Frame: Day 1
For sepsis arm, Secured second vascular access point- type (Interosseous (IO), second Intravenous (IV), central venous (CV) access) within 15 min of physician evaluation
Type of Re-hydration
Time Frame: Day 1
Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED)
Normal Saline Bolus
Time Frame: 60 minutes
For sepsis arm, 60 ml/kg Normal Saline bolus administered within 60 minutes
Antibiotic Use
Time Frame: 60 minutes
For sepsis arm, antibiotic given within 60 min
Secondary Outcomes
- Survival to Hospital Discharge(30 days)
- Left Ventricular Function(Day 1)
- Source of Sepsis(Day 1)
- Disposition Status(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(48 hours)
- 30 Day Mortality(30 days)