Trials / Withdrawn
WithdrawnNCT07191054
LifeFlow Sepsis Study
Prospective Trial Of Patient Outcomes and PALS Sepsis Guideline Adherence In Patients Fluid Resuscitated With The LifeFlow® Rapid Infuser Compared To Traditional Methods
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Phoenix Children's Hospital · Academic / Other
- Sex
- All
- Age
- 1 Year – 19 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LifeFlow Rapid infuser | Use of rapid infuser to fluid resuscitate |
| DEVICE | Push Pull | Use of Push Pull syringe technique to fluid resuscitate |
Timeline
- Start date
- 2019-05-01
- Primary completion
- 2020-03-30
- Completion
- 2020-03-30
- First posted
- 2025-09-24
- Last updated
- 2025-09-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07191054. Inclusion in this directory is not an endorsement.