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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568189
Recruitment Status : Suspended (turnover in staff, to restart with new hire)
First Posted : October 5, 2015
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
James W Tsung MD MPH, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Sepsis Gastroenteritis Dehydration Device: SonoSite Maxx Series Ultrasound System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : November 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Type of re-hydration [ Time Frame: Day 1 ]
    Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED)

  2. Vascular access point [ Time Frame: Day 1 ]
    Secured second vascular access point- type (Interosseous (IO), second Intravenous (IV), central venous (CV) access) within 15 min of physician evaluation

  3. Antibiotic use [ Time Frame: 60 minutes ]
    Antibiotic given within 60 min

  4. Normal Saline bolus [ Time Frame: 60 minutes ]
    60 ml/kg Normal Saline bolus administered within 60 minutes


Secondary Outcome Measures :
  1. Disposition Status [ Time Frame: Day 1 ]
    Pediatric Intensive Care Unit (PICU), Floor, Discharge

  2. 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) ]
  3. Return ED Visit for same illness within 48 hours [ Time Frame: 48 hours ]
    At greater than 48 hours post emergency department disposition

  4. Survival to hospital discharge [ Time Frame: 30 days ]
    At time of emergency department or hospital discharge

  5. 30 day mortality [ Time Frame: 30 days ]
    Assessed any time after 30 days from emergency department registration date.

  6. Left ventricular function [ Time Frame: Day 1 ]
    During emergency department visit

  7. Source of sepsis [ Time Frame: Day 1 ]
    During emergency department or hospital visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568189


Locations
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United States, New York
Mount Sinai Hospital Department of Emergency Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: James Tsung, MD Icahn School of Medicine at Mount Sinai
Additional Information:
Publications:
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Responsible Party: James W Tsung MD MPH, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02568189    
Other Study ID Numbers: GCO 15-1599
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Keywords provided by James W Tsung MD MPH, Icahn School of Medicine at Mount Sinai:
Sepsis
Gastroenteritis
Dehydration
Ultrasound
Ultrasonography
Inferior Vena Cava
Additional relevant MeSH terms:
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Sepsis
Toxemia
Gastroenteritis
Dehydration
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Water-Electrolyte Imbalance
Metabolic Diseases