Not provided
Not provided
Not provided
Not provided
Not provided
Study never started, no enrollments.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Life Flow | Experimental | Patients concerning for severe sepsis will receive fluid resuscitation using the LifeFlow rapid infuser |
|
| Push-Pull | Active Comparator | Patients concerning for severe sepsis will receive fluid resuscitation using the standard push/pull technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LifeFlow Rapid infuser | Device | Use of rapid infuser to fluid resuscitate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time To first bolus completion | 20 Minutes | |
| Time to third bolus completion | 60 Minutes | |
| Time to hospital admission | Time from presentation to the ER until admission to the hospital | 24 hours |
| Nursing satisfaction | Likert scale of satisfaction with style of fluid administration used. From not satisfied to extremely satisfied. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Days | |
| ICU days | Days | |
| Vasoactive medication use |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's | Phoenix | Arizona | 85016 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D058582 | Double-Balloon Enteroscopy |
| ID | Term |
|---|---|
| D000071087 | Balloon Enteroscopy |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Push Pull |
| Device |
Use of Push Pull syringe technique to fluid resuscitate |
|
Will measure whether vasoactive medications are used or not used
| 1 day |
| Morbidity and Mortality | rate of morbidity and mortality per 100 subjects in each arm | 1 day |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |