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

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 Overview

• Status: Withdrawn
• Conditions: Sepsis
• Intervention / Treatment: Device: LifeFlow Rapid infuser; Device: Push Pull

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Life Flow; Patients concerning for severe sepsis will receive fluid resuscitation using the LifeFlow rapid infuser	Device: LifeFlow Rapid infuser; Use of rapid infuser to fluid resuscitate
Active Comparator: Push-Pull; Patients concerning for severe sepsis will receive fluid resuscitation using the standard push/pull technique	Device: Push Pull; Use of Push Pull syringe technique to fluid resuscitate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay		Days
ICU days		Days
Vasoactive medication use	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

Collaborators and Investigators

• Sponsor: Phoenix Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: September 22, 2025
• First Posted (Estimated): September 24, 2025

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Balloon Enteroscopy; Double-Balloon Enteroscopy
• Other Study ID Numbers: 19-070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No