LifeFlow Sepsis Study

NCT07191054 | Withdrawn FDA Device

• 1 other identifier: 19-070
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Hospital Length of Stay

  Days

• ICU days

  Days

• Vasoactive medication use

  1 day

• Morbidity and Mortality

  1 day

Study Arms (2)

Life Flow

EXPERIMENTAL

Patients concerning for severe sepsis will receive fluid resuscitation using the LifeFlow rapid infuser

Device: LifeFlow Rapid infuser

Push-Pull

ACTIVE COMPARATOR

Patients concerning for severe sepsis will receive fluid resuscitation using the standard push/pull technique

Device: Push Pull

Interventions

LifeFlow Rapid infuser DEVICE

Use of rapid infuser to fluid resuscitate

Life Flow

Push Pull DEVICE

Use of Push Pull syringe technique to fluid resuscitate

Push-Pull

Eligibility Criteria

• Age: 1 Year - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Less than 19 years old
• Trigger the Best Practice Alert in triage
• Treating physician elects to do the full sepsis bundle.

You may not qualify if:

• Less than 20kg in weight
• Patients on diuretics for cardiac or renal conditions
• Patients who cannot communicate in either English or Spanish

Sponsors & Collaborators

• Phoenix Children's Hospital: lead

Study Sites (1)

Phoenix Children's

Phoenix, Arizona, 85016, United States

Location

MeSH Terms

Conditions

Sepsis

Interventions

Double-Balloon Enteroscopy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Balloon Enteroscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: September 24, 2025
• Study Start: May 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)