40 Participants NeededMy employer runs this trial

Non-Invasive Cardiac Output Monitoring for Sepsis

(FLUID-ED Trial)

EM
Overseen ByElizabeth Munroe, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Intermountain Health Care, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this pilot clinical trial is to learn if a fluid assessment using non-invasive cardiac output monitoring (NICOM) is helpful for patients with sepsis who have low blood pressure in the Emergency Department (ED). The study will measure whether the NICOM assessment changes fluid resuscitation practices and is feasible in the ED setting. All patients will receive standard medical care. Patients assigned to the NICOM group will receive a one-time, non-invasive bedside fluid assessment using NICOM, in addition to standard care, and the results of the fluid assessment will be provided to the treating physician.

Are You a Good Fit for This Trial?

This trial is for adults in the emergency department with sepsis and low blood pressure. People who are not eligible include those under 18, pregnant women, or anyone with conditions that make NICOM monitoring unsafe.

Inclusion Criteria

I am an adult receiving care in the Intermountain Medical Center emergency department.
I am suspected to have sepsis based on screening or a doctor's assessment.
I have low blood pressure or high lactate levels, or I am on medication to raise my blood pressure.

Exclusion Criteria

I have received or been prescribed 30 ml/kg of IV fluids based on my weight.
I do not have any serious conditions like shock, stroke, heart attack, or certain heart devices.
Patient has been in the ED for >6 hours or was transferred from an outside ED
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

Treatment

Participants receive a NICOM fluid assessment or standard care in the Emergency Department

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ICU admission and oxygen requirement

2 days
In-person monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • Non-Invasive Cardiac Output Monitoring (NICOM)

Trial Overview

The study tests if using a non-invasive heart monitor (NICOM) to guide fluid treatment helps patients with sepsis in the ER. All patients get standard care; some also get a one-time NICOM assessment to help doctors decide on fluids.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: NICOM Fluid AssessmentActive Control1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials
142
Recruited
1,965,000+