LifeFlow Sepsis Study

NCT ID: NCT07191054

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Life Flow

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

Group Type EXPERIMENTAL

LifeFlow Rapid infuser

Intervention Type DEVICE

Use of rapid infuser to fluid resuscitate

Push-Pull

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

Group Type ACTIVE_COMPARATOR

Push Pull

Intervention Type DEVICE

Use of Push Pull syringe technique to fluid resuscitate

Interventions

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LifeFlow Rapid infuser

Use of rapid infuser to fluid resuscitate

Intervention Type DEVICE

Push Pull

Use of Push Pull syringe technique to fluid resuscitate

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phoenix Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phoenix Children's

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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19-070

Identifier Type: -

Identifier Source: org_study_id

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