Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration
Status: | Suspended |
---|---|
Conditions: | Hospital, Gastrointestinal |
Therapuetic Areas: | Gastroenterology, Other |
Healthy: | No |
Age Range: | Any - 21 |
Updated: | 1/27/2019 |
Start Date: | November 2015 |
End Date: | July 2019 |
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.
inferior vena cava impacts the management and outcomes of pediatric emergency department
patients undergoing evaluation and treatment of sepsis and gastroenteritis associated
dehydration.
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 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.
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 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.
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
We found this trial at
1
site
New York, New York 10029
Principal Investigator: Elizabeth Haines, D.O.
Phone: 212-241-6272
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