SepsisNCT02568189
Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration
A study testing SonoSite Maxx Series Ultrasound System in people with Sepsis and Gastroenteritis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Sepsis, Gastroenteritis, Dehydration
- What is being tested?
- SonoSite Maxx Series Ultrasound System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Unstable patients with life-threatening injuries who require ongoing resuscitation
- Patient undergoing traumatic resuscitation
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Hospital Department of Emergency Medicine
New York, New York, 10029
About this study
Official title: Randomized Controlled Trial of Inferior Vena Cava Ultrasonography in the Management and Disposition of Pediatric Patients Undergoing Evaluation for Sepsis and Dehydration
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.
Read the 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.
- Conditions
- Sepsis, Gastroenteritis, Dehydration
- Being tested
- SonoSite Maxx Series Ultrasound System
- Keywords
- Sepsis, Gastroenteritis, Dehydration, Ultrasound, Ultrasonography, Inferior Vena Cava
- Medical subject headings
- Sepsis, Gastroenteritis, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoSite Maxx Series Ultrasound SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Device: SonoSite Maxx Series Ultrasound System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of Re-hydration
Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED)
Measured: 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
Measured: Day 1
Antibiotic Use
For sepsis arm, antibiotic given within 60 min
Measured: 60 minutes
Normal Saline Bolus
For sepsis arm, 60 ml/kg Normal Saline bolus administered within 60 minutes
Measured: 60 minutes
Secondary outcomes (7)
Disposition Status
Pediatric Intensive Care Unit (PICU), Floor, Discharge
Measured: Day 1
Length of ED Stay (From Sepsis Alert to Admission/Discharge Order Entry)
Measured: Time between emergency department registration and disposition (admit, transfer or discharge)
Return ED Visit for Same Illness Within 48 Hours
At greater than 48 hours post emergency department disposition
Measured: 48 hours
Survival to Hospital Discharge
For sepsis arm, at time of emergency department or hospital discharge
Measured: 30 days
30 Day Mortality
Assessed any time after 30 days from emergency department registration date.
Measured: 30 days
Left Ventricular Function
For sepsis arm, during emergency department visit
Measured: Day 1
Source of Sepsis
For sepsis arm, during emergency department or hospital visit
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Why it stopped: Lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James W Tsung MD MPH, Icahn School of Medicine at Mount Sinai
- Investigators
- James Tsung, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568189
- Sponsor's protocol ID
- GCO 15-1599
- Status last verified
- Jun 2024
- First submitted
- 1 Oct 2015
- Last updated
- 13 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 15286547
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Inferior Vena Cava Ultrasonography in the Management and Disposition of Pediatric Patients Undergoing Evaluation for Sepsis and Dehydration
- ClinicalTrials.gov ID
- NCT02568189
- Acronym / sponsor ID
- GCO 15-1599
- Conditions
- Sepsis, Gastroenteritis, Dehydration
- Keywords
- Sepsis, Gastroenteritis, Dehydration, Ultrasound, Ultrasonography, Inferior Vena Cava
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of resources
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Posted 13 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sepsis 1 | Experimental | Device: SonoSite Maxx Series Ultrasound SystemSepsis 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 | Device: SonoSite Maxx Series Ultrasound SystemSepsis patients having SonoSite Maxx Series Ultrasound System ultrasound performed after clinical orders have been placed by the treating physician |
| Gastroenteritis 1 | Experimental | Device: SonoSite Maxx Series Ultrasound SystemPatients with gastroenteritis receiving SonoSite Maxx Series Ultrasound System ultrasound prior to having orders placed by treating physician |
| Gastroenteritis 2 | Active comparator | Device: SonoSite Maxx Series Ultrasound SystemPatients with gastroenteritis having SonoSite Maxx Series Ultrasound System ultrasound after initial clinical orders are placed by treating physician |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unstable patients with life-threatening injuries who require ongoing resuscitation
- Patient undergoing traumatic resuscitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonoSite Maxx Series Ultrasound SystemUltrasound 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. | Device | Gastroenteritis 1, Gastroenteritis 2, Sepsis 1, Sepsis 2 |
Primary outcome
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)
Vascular Access Point
Time frame: 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
Time frame: 60 minutes
For sepsis arm, antibiotic given within 60 min
Normal Saline Bolus
Time frame: 60 minutes
For sepsis arm, 60 ml/kg Normal Saline bolus administered within 60 minutes
7 secondary outcomes
Disposition Status
Time frame: Day 1
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)
Return ED Visit for Same Illness Within 48 Hours
Time frame: 48 hours
Survival to Hospital Discharge
Time frame: 30 days
30 Day Mortality
Time frame: 30 days
Left Ventricular Function
Time frame: Day 1
Source of Sepsis
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15286547Jones 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.
- Article By Jones on goal directed ultrasoundLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Tsung, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SonoSite Maxx Series Ultrasound System in people with Sepsis and Gastroenteritis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of Re-hydration (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02568189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.