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LifeFlow Sepsis Study

NCT07191054 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-09-24

No results posted yet for this study

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

Interventions

DEVICE

LifeFlow Rapid infuser

Use of rapid infuser to fluid resuscitate

DEVICE

Push Pull

Use of Push Pull syringe technique to fluid resuscitate

Sponsors & Collaborators

  • Phoenix Children's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-03-30
Completion
2020-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07191054 on ClinicalTrials.gov