Clinical trial NCT02568189: Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration
Official title: Randomized Controlled Trial of Inferior Vena Cava Ultrasonography in the Management and Disposition of Pediatric Patients Undergoing Evaluation for Sepsis and Dehydration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sepsis
Gastroenteritis
Dehydration
Keywords: Sepsis
Gastroenteritis
Dehydration
Ultrasound
Ultrasonography
Inferior Vena Cava
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 112
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Type of Re-hydration
timeFrame: Day 1
measure: Vascular Access Point
timeFrame: Day 1
measure: Antibiotic Use
timeFrame: 60 minutes
measure: Normal Saline Bolus
timeFrame: 60 minutes
Secondary outcomes:
measure: Disposition Status
timeFrame: Day 1
measure: Length of ED Stay (From Sepsis Alert to Admission/Discharge Order Entry)
timeFrame: Time between emergency department registration and disposition (admit, transfer or discharge)
measure: Return ED Visit for Same Illness Within 48 Hours
timeFrame: 48 hours
measure: Survival to Hospital Discharge
timeFrame: 30 days
measure: 30 Day Mortality
timeFrame: 30 days
measure: Left Ventricular Function
timeFrame: Day 1
measure: Source of Sepsis
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital Department of Emergency Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: James Tsung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones AE, Tayal VS, Sullivan DM, Kline JA. Randomized, controlled trial of immediate versus delayed goal-directed ultrasound to identify the cause of nontraumatic hypotension in emergency department patients. Crit Care Med. 2004 Aug;32(8):1703-8. doi: 10.1097/01.ccm.0000133017.34137.82.