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

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

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.

Study Overview

• Status: Terminated
• Conditions: Sepsis; Gastroenteritis; Dehydration
• Intervention / Treatment: Device: SonoSite Maxx Series Ultrasound System

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital Department of Emergency Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sepsis 1; 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; 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.
Active Comparator: Sepsis 2; 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; 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.
Experimental: Gastroenteritis 1; Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician	Device: SonoSite Maxx Series Ultrasound System; 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.
Active Comparator: Gastroenteritis 2; 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; 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.

What is the study measuring?

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	For sepsis arm, 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	For sepsis arm, antibiotic given within 60 min	60 minutes
Normal Saline Bolus	For sepsis arm, 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	For sepsis arm, 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	For sepsis arm, during emergency department visit	Day 1
Source of Sepsis	For sepsis arm, during emergency department or hospital visit	Day 1

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: James Tsung, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.

Helpful Links

• Article By Jones on goal directed ultrasound

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (Estimated): October 5, 2015

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Gastroenteritis; Dehydration; Sepsis; Ultrasonography; Inferior Vena Cava
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Gastrointestinal Diseases; Water-Electrolyte Imbalance; Sepsis; Toxemia; Gastroenteritis; Dehydration
• Other Study ID Numbers: GCO 15-1599