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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02568189
• Other study ID #: GCO 15-1599
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: June 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Dehydration
• Gastroenteritis
• Sepsis
• Toxemia

Intervention

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.

Locations

Country	Name	City	State
United States	Mount Sinai Hospital Department of Emergency Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type of Re-hydration	Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED)	Day 1
Primary	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
Primary	Antibiotic Use	For sepsis arm, antibiotic given within 60 min	60 minutes
Primary	Normal Saline Bolus	For sepsis arm, 60 ml/kg Normal Saline bolus administered within 60 minutes	60 minutes
Secondary	Disposition Status	Pediatric Intensive Care Unit (PICU), Floor, Discharge	Day 1
Secondary	Length of ED Stay (From Sepsis Alert to Admission/Discharge Order Entry)		Time between emergency department registration and disposition (admit, transfer or discharge)
Secondary	Return ED Visit for Same Illness Within 48 Hours	At greater than 48 hours post emergency department disposition	48 hours
Secondary	Survival to Hospital Discharge	For sepsis arm, at time of emergency department or hospital discharge	30 days
Secondary	30 Day Mortality	Assessed any time after 30 days from emergency department registration date.	30 days
Secondary	Left Ventricular Function	For sepsis arm, during emergency department visit	Day 1
Secondary	Source of Sepsis	For sepsis arm, during emergency department or hospital visit	Day 1

External Links

•   Article By Jones on goal directed ultrasound