NCT02568189

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Gastroenteritis
• Dehydration

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2015-10-05
• Last updated: 2024-06-13
• Results posted: 2024-06-13

Locations

1 site across 1 country: United States