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

Not Applicable

Terminated

• Conditions: Dehydration; Gastroenteritis; Sepsis
• Interventions: Device: SonoSite Maxx Series Ultrasound System

• Registration Number: NCT02568189
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-05
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Disposition First Submitted: 2023-12-29
• Disposition First Posted: 2024-01-18
• Results First Submitted: 2024-05-10
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-11
• Last Update Submitted: 2024-06-11
• Results First Posted: 2024-06-13
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 112

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

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Exclusion Criteria

• Unstable patients with life-threatening injuries who require ongoing resuscitation
• Patient undergoing traumatic resuscitation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sepsis 1	SonoSite Maxx Series Ultrasound System	Sepsis patients receiving SonoSite Maxx Series Ultrasound System ultrasound prior to clinical orders including medication and fluid orders being placed by the treating physician
Gastroenteritis 1	SonoSite Maxx Series Ultrasound System	Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician
Gastroenteritis 2	SonoSite Maxx Series Ultrasound System	Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician
Sepsis 2	SonoSite Maxx Series Ultrasound System	Sepsis patients having SonoSite Maxx Series Ultrasound System ultrasound performed after clinical orders have been placed by the treating physician

Primary Outcome Measures

Name	Time	Method
Vascular Access Point	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	Day 1	Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED)
Normal Saline Bolus	60 minutes	For sepsis arm, 60 ml/kg Normal Saline bolus administered within 60 minutes
Antibiotic Use	60 minutes	For sepsis arm, antibiotic given within 60 min

Secondary Outcome Measures

Name	Time	Method
Survival to Hospital Discharge	30 days	For sepsis arm, at time of emergency department or hospital discharge
Left Ventricular Function	Day 1	For sepsis arm, during emergency department visit
Source of Sepsis	Day 1	For sepsis arm, during emergency department or hospital visit
Disposition Status	Day 1	Pediatric Intensive Care Unit (PICU), Floor, Discharge
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	At greater than 48 hours post emergency department disposition
30 Day Mortality	30 days	Assessed any time after 30 days from emergency department registration date.

Trial Locations

Locations (1)

Mount Sinai Hospital Department of Emergency Medicine; 🇺🇸 New York, New York, United States