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

NCT02568189 | Terminated Results DMC

• 1 other identifier: GCO 15-1599
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Gastroenteritis; Dehydration

Keywords

Sepsis; Gastroenteritis; Dehydration; Ultrasound; Ultrasonography; Inferior Vena Cava

Outcome Measures

Primary Outcomes (4)

• Type of Re-hydration

  Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED)

  Day 1

• 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

• Antibiotic Use

  For sepsis arm, antibiotic given within 60 min

  60 minutes

• Normal Saline Bolus

  For sepsis arm, 60 ml/kg Normal Saline bolus administered within 60 minutes

  60 minutes

Secondary Outcomes (7)

• Disposition Status

  Day 1

• Length of ED Stay (From Sepsis Alert to Admission/Discharge Order Entry)

  Time between emergency department registration and disposition (admit, transfer or discharge)

• Return ED Visit for Same Illness Within 48 Hours

  48 hours

• Survival to Hospital Discharge

  30 days

• 30 Day Mortality

  30 days

Study Arms (4)

Sepsis 1

EXPERIMENTAL

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

Sepsis 2

ACTIVE COMPARATOR

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

Gastroenteritis 1

EXPERIMENTAL

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

Device: SonoSite Maxx Series Ultrasound System

Gastroenteritis 2

ACTIVE COMPARATOR

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

Interventions

SonoSite Maxx Series Ultrasound System DEVICE

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.

Gastroenteritis 1; Gastroenteritis 2; Sepsis 1; Sepsis 2

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unstable patients with life-threatening injuries who require ongoing resuscitation
• Patient undergoing traumatic resuscitation

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital Department of Emergency Medicine

New York, New York, 10029, United States

Location

Related 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.

  PMID: 15286547 BACKGROUND

Related Links

• Article By Jones on goal directed ultrasound

MeSH Terms

Conditions

Sepsis; Gastroenteritis; Dehydration

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: James W Tsung MD, MPH
• Organization: Icahn School of Medicine at Mount Sinai

james.tsung@mountsinai.org

212 241 6272

Study Officials

• James Tsung, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 5, 2015
• Study Start: October 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: June 13, 2024
• Results First Posted: June 13, 2024

Record last verified: 2024-06

Locations

US (1)