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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Sepsis 2 | Active Comparator | Sepsis patients having SonoSite Maxx Series Ultrasound System ultrasound performed after clinical orders have been placed by the treating physician |
|
| Gastroenteritis 1 | Experimental | Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician |
|
| Gastroenteritis 2 | Active Comparator | Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disposition Status | Pediatric Intensive Care Unit (PICU), Floor, Discharge | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Tsung, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital Department of Emergency Medicine | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15286547 | Background | 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. |
| Label | URL |
|---|---|
| Article By Jones on goal directed ultrasound | View source |
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112 participants and enrolled. 6 participants with inferior vena cava not visualized on ultrasound. These participants were not randomized.
Study Halted when Misclassification of Study Outcome Discovered (Different IVC Collapse criteria on IVC Ultrasound)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| FG001 | Sepsis 2 | Sepsis patients having SonoSite Maxx Series Ultrasound System ultrasound performed after clinical orders have been placed by the treating physician 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. |
| FG002 | Gastroenteritis 1 | Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician 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. |
| FG003 | Gastroenteritis 2 | Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
no enrollment for sepsis arms
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Type of Re-hydration | Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED) | Posted | Count of Participants | Participants | Day 1 |
|
30 days
No participants enrolled in Sepsis arms
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James W Tsung MD, MPH | Icahn School of Medicine at Mount Sinai | 212 241 6272 | james.tsung@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 26, 2015 | May 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 2, 2024 | May 6, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2015 | May 6, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D005759 | Gastroenteritis |
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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|
| Return ED Visit for Same Illness Within 48 Hours | At greater than 48 hours post emergency department disposition | 48 hours |
| Survival to Hospital Discharge | For sepsis arm, at time of emergency department or hospital discharge | 30 days |
| 30 Day Mortality | Assessed any time after 30 days from emergency department registration date. | 30 days |
| Left Ventricular Function | For sepsis arm, during emergency department visit | Day 1 |
| Source of Sepsis | For sepsis arm, during emergency department or hospital visit | Day 1 |
| BG001 | Sepsis 2 | Sepsis patients having SonoSite Maxx Series Ultrasound System ultrasound performed after clinical orders have been placed by the treating physician 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. |
| BG002 | Gastroenteritis 1 | Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician 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. |
| BG003 | Gastroenteritis 2 | Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Inferior Vena Cava Status | Count of Participants | Participants |
|
| Gastroenteritis 2 (Delayed) |
Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician 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 | 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 | Outcome measure for sepsis arms | Posted | Day 1 |
|
|
| Primary | Antibiotic Use | For sepsis arm, antibiotic given within 60 min | Outcome measure for sepsis arms | Posted | 60 minutes |
|
|
| Primary | Normal Saline Bolus | For sepsis arm, 60 ml/kg Normal Saline bolus administered within 60 minutes | Outcome measure for sepsis arms | Posted | 60 minutes |
|
|
| Secondary | Disposition Status | Pediatric Intensive Care Unit (PICU), Floor, Discharge | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Length of ED Stay (From Sepsis Alert to Admission/Discharge Order Entry) | No participants enrolled in Sepsis arms | Posted | Mean | Standard Deviation | minutes | Time between emergency department registration and disposition (admit, transfer or discharge) |
|
|
|
| Secondary | Return ED Visit for Same Illness Within 48 Hours | At greater than 48 hours post emergency department disposition | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| Secondary | Survival to Hospital Discharge | For sepsis arm, at time of emergency department or hospital discharge | Outcome measure for sepsis arms | Posted | 30 days |
|
|
| Secondary | 30 Day Mortality | Assessed any time after 30 days from emergency department registration date. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Left Ventricular Function | For sepsis arm, during emergency department visit | Outcome measure for sepsis arms | Posted | Day 1 |
|
|
| Secondary | Source of Sepsis | For sepsis arm, during emergency department or hospital visit | Outcome measure for sepsis arms | Posted | Day 1 |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Sepsis 2 | Sepsis patients having SonoSite Maxx Series Ultrasound System ultrasound performed after clinical orders have been placed by the treating physician 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Gastroenteritis 1 | Patients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician 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. | 0 | 52 | 0 | 52 | 0 | 52 |
| EG003 | Gastroenteritis 2 | Patients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician 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. | 0 | 54 | 0 | 54 | 0 | 54 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Not Visualized |
|
| Discharge |
|