LifeFlow Sepsis Study

Phoenix Children's Hospital

Status: Withdrawn

Conditions: Sepsis

Treatments: Device: LifeFlow Rapid infuser; Device: Push Pull

Study type: Interventional

Funder types: Other

Identifiers

NCT07191054

19-070

Details and patient eligibility

About

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.

Sex: All

Ages: 1 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Life Flow

Experimental group

Description:

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

Treatment:

Device: LifeFlow Rapid infuser

Push-Pull

Active Comparator group

Description:

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

Treatment:

Device: Push Pull