SepsisPOCUS SepsisNCT05544903
Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department
An observational study of Sepsis, run by Northwell Health at 1 site in United States.
Trial summary
The FloPatch device will be applied to 150 septic patients in the emergency department before they receive fluid resuscitation. This study will assess whether initial FloPatch measured volume-responsiveness and volume of fluids used will predict a composite outcome of mortality, intensive care unit admission, or rapid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 18 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the emergency department who meet sepsis criteria based on presenting vital signs will be eligible for the study.
Who may be able to join
- Emergency department patient
- 18+ years old
- Systolic blood pressure less than 100mmHg
- Respiratory rate greater than 22 breaths per minutes
- Temperature greater than 38 degrees Celsius or less than 36 degrees Celsius
- Heart rate greater than 90 beats per minute
Who cannot join
- Already intubated prior to emergency department arrival
- Ventilator-dependent
- Patients transferred from another hospital
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital
Manhasset, New York, 11030
About this study
Official title: The Use of Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department
The FloPatch device will be applied to 150 septic patients in the emergency department before they receive fluid resuscitation. This study will assess whether initial FloPatch measured volume-responsiveness and volume of fluids used will predict a composite outcome of mortality, intensive care unit admission, or rapid response team activation. The development of fluid unresponsiveness throughout the initial fluid resuscitation will be assessed and its association with the composite outcome will be assessed.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mortality, ICU admission, or rapid response team activation | Carotid flow patterns and velocity time integral values, as determined by FloPatch. | |
| No mortality, ICU admission, or rapid response team activation | Carotid flow patterns and velocity time integral values, as determined by FloPatch. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
This study will ascertain whether the patient died within 24 hours of ED arrival.
Measured: 24 hours
ICU admission
This study will ascertain whether the patient was admitted to the ICU within 24 hours of ED arrival.
Measured: 24 hours
Rapid response team activation
This study will ascertain whether a rapid response team was activated for the patient within 24 hours of ED arrival.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Sep 2022
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Flosonics Medical
- Responsible party
- Sponsor
- Investigators
- Allison Cohen, MD, Principal investigator, North Shore University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544903
- Sponsor's protocol ID
- 20-0151
- Acronym
- POCUS Sepsis
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Point of Care Ultrasound to Predict Intensive Care Unit Admission of Patients Presenting With Sepsis to the Emergency Department
- ClinicalTrials.gov ID
- NCT05544903
- Acronym / sponsor ID
- POCUS Sepsis / 20-0151
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Flosonics Medical
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The FloPatch device will be applied to 150 septic patients in the emergency department before they receive fluid resuscitation. This study will assess whether initial FloPatch measured volume-responsiveness and volume of fluids used will predict a composite outcome of mortality, intensive care unit admission, or rapid response team activation. The development of fluid unresponsiveness throughout the initial fluid resuscitation will be assessed and its association with the composite outcome will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mortality, ICU admission, or rapid response team activation | – | –Carotid flow patterns and velocity time integral values, as determined by FloPatch. |
| No mortality, ICU admission, or rapid response team activation | – | –Carotid flow patterns and velocity time integral values, as determined by FloPatch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the emergency department who meet sepsis criteria based on presenting vital signs will be eligible for the study.
Key inclusion criteria (6 listed)
- Emergency department patient
- 18+ years old
- Systolic blood pressure less than 100mmHg
- Respiratory rate greater than 22 breaths per minutes
- Temperature greater than 38 degrees Celsius or less than 36 degrees Celsius
Key exclusion criteria (4 listed)
- Already intubated prior to emergency department arrival
- Ventilator-dependent
- Patients transferred from another hospital
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 24 hours
This study will ascertain whether the patient died within 24 hours of ED arrival.
ICU admission
Time frame: 24 hours
This study will ascertain whether the patient was admitted to the ICU within 24 hours of ED arrival.
Rapid response team activation
Time frame: 24 hours
This study will ascertain whether a rapid response team was activated for the patient within 24 hours of ED arrival.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Ventilator-Induced Lung Injury, Sepsis Syndrome
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
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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.
Allison Cohen, MD principal investigator
North Shore University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Northwell Health 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 15 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.