SepsisNCT07191054
LifeFlow Sepsis Study
A study testing LifeFlow Rapid infuser and Push Pull in people with Sepsis, run by Phoenix Children's Hospital at 1 site in United States.
Trial summary
This is a prospective, comparative, blinded, randomized study to prove the safety, efficacy and ease of use of the LifeFlow® device in pediatric patients presenting to an emergency department with concern for sepsis. Read more about this study
- Who is it for?
- Ages 1 year to 19 years
- Conditions the study is for
- Sepsis
- What is being tested?
- LifeFlow Rapid infuser and Push Pull
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 30 Mar 2020
- Phase
- Interventional
- 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 1 year to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Less than 19 years old
- Trigger the Best Practice Alert in triage
- Treating physician elects to do the full sepsis bundle.
Who cannot join
- Less than 20kg in weight
- Patients on diuretics for cardiac or renal conditions
- Patients who cannot communicate in either English or Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Trial Of Patient Outcomes and PALS Sepsis Guideline Adherence In Patients Fluid Resuscitated With The LifeFlow® Rapid Infuser Compared To Traditional Methods
This is a prospective, comparative, blinded, randomized study to prove the safety, efficacy and ease of use of the LifeFlow® device in pediatric patients presenting to an emergency department with concern for sepsis. This study will include 600 patients, 300 will receive the LifeFlow® device to deliver intravenous fluids while another 300 patients will receive the conventional push/pull method.
- Conditions
- Sepsis
- Being tested
- LifeFlow Rapid infuser, Push Pull
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeFlow Rapid infuserDevice
Use of rapid infuser to fluid resuscitate
Push PullDevice
Use of Push Pull syringe technique to fluid resuscitate
| Study group | Role | What they receive |
|---|---|---|
| Life Flow | Experimental | Patients concerning for severe sepsis will receive fluid resuscitation using the LifeFlow rapid infuser Receives: Device: LifeFlow Rapid infuser |
| Push-Pull | Active comparator | Patients concerning for severe sepsis will receive fluid resuscitation using the standard push/pull technique Receives: Device: Push Pull |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To first bolus completion
Measured: 20 Minutes
Time to third bolus completion
Measured: 60 Minutes
Time to hospital admission
Time from presentation to the ER until admission to the hospital
Measured: 24 hours
Nursing satisfaction
Likert scale of satisfaction with style of fluid administration used. From not satisfied to extremely satisfied.
Measured: 1 day
Secondary outcomes (4)
Hospital Length of Stay
Measured: Days
ICU days
Measured: Days
Vasoactive medication use
Will measure whether vasoactive medications are used or not used
Measured: 1 day
Morbidity and Mortality
rate of morbidity and mortality per 100 subjects in each arm
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 May 2019 (estimated)
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Why it stopped: Study never started, no enrollments.
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191054
- Sponsor's protocol ID
- 19-070
- Status last verified
- Sep 2025
- First submitted
- 17 Apr 2019
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial Of Patient Outcomes and PALS Sepsis Guideline Adherence In Patients Fluid Resuscitated With The LifeFlow® Rapid Infuser Compared To Traditional Methods
- ClinicalTrials.gov ID
- NCT07191054
- Acronym / sponsor ID
- 19-070
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started, no enrollments.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 24 Sep 2025 (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.
This is a prospective, comparative, blinded, randomized study to prove the safety, efficacy and ease of use of the LifeFlow® device in pediatric patients presenting to an emergency department with concern for sepsis. This study will include 600 patients, 300 will receive the LifeFlow® device to deliver intravenous fluids while another 300 patients will receive the conventional push/pull method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Life Flow | Experimental | Device: LifeFlow Rapid infuserPatients concerning for severe sepsis will receive fluid resuscitation using the LifeFlow rapid infuser |
| Push-Pull | Active comparator | Device: Push PullPatients concerning for severe sepsis will receive fluid resuscitation using the standard push/pull technique |
Who may qualify
- Ages
- 1 year to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Less than 19 years old
- Trigger the Best Practice Alert in triage
- Treating physician elects to do the full sepsis bundle.
Key exclusion criteria (3 listed)
- Less than 20kg in weight
- Patients on diuretics for cardiac or renal conditions
- Patients who cannot communicate in either English or Spanish
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 |
|---|---|---|
| LifeFlow Rapid infuserUse of rapid infuser to fluid resuscitate | Device | Life Flow |
| Push PullUse of Push Pull syringe technique to fluid resuscitate | Device | Push-Pull |
Primary outcome
Time To first bolus completion
Time frame: 20 Minutes
Time to third bolus completion
Time frame: 60 Minutes
Time to hospital admission
Time frame: 24 hours
Time from presentation to the ER until admission to the hospital
Nursing satisfaction
Time frame: 1 day
Likert scale of satisfaction with style of fluid administration used. From not satisfied to extremely satisfied.
4 secondary outcomes
Hospital Length of Stay
Time frame: Days
ICU days
Time frame: Days
Vasoactive medication use
Time frame: 1 day
Morbidity and Mortality
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeFlow Rapid infuser and Push Pull in people with Sepsis, run by Phoenix Children's Hospital 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 3 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: withdrawn, as of the sponsor's last update on 24 Sep 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Time To first bolus completion (time frame: 20 Minutes). 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?
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 24 Sep 2025.