Sepsis
Conditions
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.
Interventions
DEVICELifeFlow Rapid infuser
Use of rapid infuser to fluid resuscitate
DEVICEPush Pull
Use of Push Pull syringe technique to fluid resuscitate
Sponsors
Phoenix Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Less than 19 years old * Trigger the Best Practice Alert in triage * Treating physician elects to do the full sepsis bundle.
Exclusion criteria
* Less than 20kg in weight * Patients on diuretics for cardiac or renal conditions * Patients who cannot communicate in either English or Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nursing satisfaction | 1 day | Likert scale of satisfaction with style of fluid administration used. From not satisfied to extremely satisfied. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed