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

Primary Purpose

Sepsis, Gastroenteritis, Dehydration

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SonoSite Maxx Series Ultrasound System
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sepsis focused on measuring Sepsis, Gastroenteritis, Dehydration, Ultrasound, Ultrasonography, Inferior Vena Cava

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Hospital Department of Emergency Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Sepsis 1

Sepsis 2

Gastroenteritis 1

Gastroenteritis 2

Arm Description

Sepsis patients receiving SonoSite Maxx Series Ultrasound System ultrasound prior to clinical orders including medication and fluid orders being placed by the treating physician

Sepsis patients having SonoSite Maxx Series Ultrasound System ultrasound performed after clinical orders have been placed by the treating physician

Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician

Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician

Outcomes

Primary Outcome Measures

Type of re-hydration
Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED)
Vascular access point
Secured second vascular access point- type (Interosseous (IO), second Intravenous (IV), central venous (CV) access) within 15 min of physician evaluation
Antibiotic use
Antibiotic given within 60 min
Normal Saline bolus
60 ml/kg Normal Saline bolus administered within 60 minutes

Secondary Outcome Measures

Disposition Status
Pediatric Intensive Care Unit (PICU), Floor, Discharge
Length of ED stay (from sepsis alert to admission/discharge order entry)
Return ED Visit for same illness within 48 hours
At greater than 48 hours post emergency department disposition
Survival to hospital discharge
At time of emergency department or hospital discharge
30 day mortality
Assessed any time after 30 days from emergency department registration date.
Left ventricular function
During emergency department visit
Source of sepsis
During emergency department or hospital visit

Full Information

First Posted
October 1, 2015
Last Updated
January 17, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT02568189
Brief Title
Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration
Official Title
Randomized Controlled Trial of Inferior Vena Cava Ultrasonography in the Management and Disposition of Pediatric Patients Undergoing Evaluation for Sepsis and Dehydration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Suspended
Why Stopped
Staff Shortage due to pandemic
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Gastroenteritis, Dehydration
Keywords
Sepsis, Gastroenteritis, Dehydration, Ultrasound, Ultrasonography, Inferior Vena Cava

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
564 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sepsis 1
Arm Type
Experimental
Arm Description
Sepsis patients receiving SonoSite Maxx Series Ultrasound System ultrasound prior to clinical orders including medication and fluid orders being placed by the treating physician
Arm Title
Sepsis 2
Arm Type
Active Comparator
Arm Description
Sepsis patients having SonoSite Maxx Series Ultrasound System ultrasound performed after clinical orders have been placed by the treating physician
Arm Title
Gastroenteritis 1
Arm Type
Experimental
Arm Description
Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician
Arm Title
Gastroenteritis 2
Arm Type
Active Comparator
Arm Description
Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician
Intervention Type
Device
Intervention Name(s)
SonoSite Maxx Series Ultrasound System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Type of re-hydration
Description
Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED)
Time Frame
Day 1
Title
Vascular access point
Description
Secured second vascular access point- type (Interosseous (IO), second Intravenous (IV), central venous (CV) access) within 15 min of physician evaluation
Time Frame
Day 1
Title
Antibiotic use
Description
Antibiotic given within 60 min
Time Frame
60 minutes
Title
Normal Saline bolus
Description
60 ml/kg Normal Saline bolus administered within 60 minutes
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Disposition Status
Description
Pediatric Intensive Care Unit (PICU), Floor, Discharge
Time Frame
Day 1
Title
Length of ED stay (from sepsis alert to admission/discharge order entry)
Time Frame
Time between emergency department registration and disposition (admit, transfer or discharge)
Title
Return ED Visit for same illness within 48 hours
Description
At greater than 48 hours post emergency department disposition
Time Frame
48 hours
Title
Survival to hospital discharge
Description
At time of emergency department or hospital discharge
Time Frame
30 days
Title
30 day mortality
Description
Assessed any time after 30 days from emergency department registration date.
Time Frame
30 days
Title
Left ventricular function
Description
During emergency department visit
Time Frame
Day 1
Title
Source of sepsis
Description
During emergency department or hospital visit
Time Frame
Day 1

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Tsung, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital Department of Emergency Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15286547
Citation
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/15286547
Description
Article By Jones on goal directed ultrasound

Learn more about this trial

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

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