LifeFlow Sepsis Study
- Conditions
- Sepsis
- Registration Number
- NCT07191054
- Lead Sponsor
- Phoenix Children's Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Less than 19 years old
- Trigger the Best Practice Alert in triage
- Treating physician elects to do the full sepsis bundle.
- Less than 20kg in weight
- Patients on diuretics for cardiac or renal conditions
- Patients who cannot communicate in either English or Spanish
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time To first bolus completion 20 Minutes Time to third bolus completion 60 Minutes Time to hospital admission 24 hours Time from presentation to the ER until admission to the hospital
Nursing satisfaction 1 day Likert scale of satisfaction with style of fluid administration used. From not satisfied to extremely satisfied.
- Secondary Outcome Measures
Name Time Method Hospital Length of Stay Days ICU days Days Vasoactive medication use 1 day Will measure whether vasoactive medications are used or not used
Morbidity and Mortality 1 day rate of morbidity and mortality per 100 subjects in each arm
Trial Locations
- Locations (1)
Phoenix Children's
🇺🇸Phoenix, Arizona, United States
Phoenix Children's🇺🇸Phoenix, Arizona, United States