Dehydration, Gastroenteritis, Sepsis
Conditions
Keywords
Sepsis, Gastroenteritis, Dehydration, Ultrasound, Ultrasonography, Inferior Vena Cava
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 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.
Interventions
DEVICESonoSite 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.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type of Re-hydration | Day 1 | Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED) |
| Vascular Access Point | Day 1 | For sepsis arm, Secured second vascular access point- type (Interosseous (IO), second Intravenous (IV), central venous (CV) access) within 15 min of physician evaluation |
| Antibiotic Use | 60 minutes | For sepsis arm, antibiotic given within 60 min |
| Normal Saline Bolus | 60 minutes | For sepsis arm, 60 ml/kg Normal Saline bolus administered within 60 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30 Day Mortality | 30 days | Assessed any time after 30 days from emergency department registration date. |
| Disposition Status | Day 1 | Pediatric Intensive Care Unit (PICU), Floor, Discharge |
| Source of Sepsis | Day 1 | For sepsis arm, during emergency department or hospital visit |
| Left Ventricular Function | Day 1 | For sepsis arm, during emergency department visit |
| 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 | At greater than 48 hours post emergency department disposition |
| Survival to Hospital Discharge | 30 days | For sepsis arm, at time of emergency department or hospital discharge |
Countries
United States
Participant flow
Recruitment details
Study Halted when Misclassification of Study Outcome Discovered (Different IVC Collapse criteria on IVC Ultrasound)
Pre-assignment details
112 participants and enrolled. 6 participants with inferior vena cava not visualized on ultrasound. These participants were not randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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 |
| 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. | 52 |
| 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. | 54 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 0 | 19 | 18 |
Baseline characteristics
| Characteristic | Gastroenteritis 1 | Gastroenteritis 2 | Total |
|---|---|---|---|
| Age, Continuous | 6.93 years STANDARD_DEVIATION 6.1 | 7.54 years STANDARD_DEVIATION 6.31 | 7.2 years STANDARD_DEVIATION 6.2 |
| Inferior Vena Cava Status IVC Collapse | 39 Participants | 36 Participants | 75 Participants |
| Inferior Vena Cava Status No IVC Collapse | 11 Participants | 17 Participants | 28 Participants |
| Inferior Vena Cava Status Not Visualized | 2 Participants | 1 Participants | 3 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 27 Participants | 26 Participants | 53 Participants |
| Sex: Female, Male Male | 25 Participants | 28 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 52 | 0 / 54 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 52 | 0 / 54 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 52 | 0 / 54 |
Outcome results
Primary
Antibiotic Use
For sepsis arm, antibiotic given within 60 min
Time frame: 60 minutes
Population: Outcome measure for sepsis arms
Primary
Normal Saline Bolus
For sepsis arm, 60 ml/kg Normal Saline bolus administered within 60 minutes
Time frame: 60 minutes
Population: Outcome measure for sepsis arms
Primary
Type of Re-hydration
Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED)
Time frame: Day 1
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gastroenteritis 1 (Immediate) | Type of Re-hydration | Oral Rehydration | 38 Participants |
| Gastroenteritis 1 (Immediate) | Type of Re-hydration | IV Rehydration | 14 Participants |
| Gastroenteritis 2 (Delayed) | Type of Re-hydration | Oral Rehydration | 45 Participants |
| Gastroenteritis 2 (Delayed) | Type of Re-hydration | IV Rehydration | 9 Participants |
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
Time frame: Day 1
Population: Outcome measure for sepsis arms
Secondary
30 Day Mortality
Assessed any time after 30 days from emergency department registration date.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gastroenteritis 1 (Immediate) | 30 Day Mortality | 0 Participants |
| Gastroenteritis 2 (Delayed) | 30 Day Mortality | 0 Participants |
Secondary
Disposition Status
Pediatric Intensive Care Unit (PICU), Floor, Discharge
Time frame: Day 1
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gastroenteritis 1 (Immediate) | Disposition Status | Floor | 3 Participants |
| Gastroenteritis 1 (Immediate) | Disposition Status | Discharge | 49 Participants |
| Gastroenteritis 1 (Immediate) | Disposition Status | PICU | 0 Participants |
| Gastroenteritis 2 (Delayed) | Disposition Status | Floor | 2 Participants |
| Gastroenteritis 2 (Delayed) | Disposition Status | Discharge | 52 Participants |
| Gastroenteritis 2 (Delayed) | Disposition Status | PICU | 0 Participants |
Secondary
Left Ventricular Function
For sepsis arm, during emergency department visit
Time frame: Day 1
Population: Outcome measure for sepsis arms
Secondary
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)
Population: No participants enrolled in Sepsis arms
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gastroenteritis 1 | Length of ED Stay (From Sepsis Alert to Admission/Discharge Order Entry) | 200 minutes | Standard Deviation 121 |
| Gastroenteritis 2 | Length of ED Stay (From Sepsis Alert to Admission/Discharge Order Entry) | 177 minutes | Standard Deviation 106 |
Secondary
Return ED Visit for Same Illness Within 48 Hours
At greater than 48 hours post emergency department disposition
Time frame: 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gastroenteritis 1 (Immediate) | Return ED Visit for Same Illness Within 48 Hours | 0 Participants |
| Gastroenteritis 2 (Delayed) | Return ED Visit for Same Illness Within 48 Hours | 0 Participants |
Secondary
Source of Sepsis
For sepsis arm, during emergency department or hospital visit
Time frame: Day 1
Population: Outcome measure for sepsis arms
Secondary
Survival to Hospital Discharge
For sepsis arm, at time of emergency department or hospital discharge
Time frame: 30 days
Population: Outcome measure for sepsis arms