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?

This trial aims to determine whether non-invasive cardiac output monitoring (NICOM) can help doctors manage fluids more effectively for patients with sepsis, a serious infection that causes low blood pressure. The study will assess whether NICOM alters fluid administration and its practicality in the emergency department. Suitable candidates include patients with suspected sepsis who also exhibit low blood pressure or high lactate levels, indicating severe infection.

As an unphased trial, this study provides patients the chance to contribute to significant research that could enhance emergency care for sepsis.

What prior data suggests that this non-invasive cardiac output monitoring is safe for patients with sepsis?

Research has shown that Non-Invasive Cardiac Output Monitoring (NICOM) is generally easy for patients to handle. Studies have found that NICOM is a safe and helpful tool for managing fluid levels in people with septic shock, a serious infection that can cause very low blood pressure. These studies indicate that NICOM helps doctors determine the right amount of fluids needed for treatment without causing significant side effects. Because NICOM is non-invasive, it doesn't involve needles or surgeries, reducing the risk of complications. Overall, hospitals have successfully used NICOM to guide treatment decisions without harming patients.12345

Why are researchers excited about this trial?

Researchers are excited about Non-Invasive Cardiac Output Monitoring (NICOM) for sepsis because it offers a way to assess a patient's fluid status without the need for invasive procedures like catheters. Unlike traditional methods that might require inserting devices into the body, NICOM uses external sensors to measure heart function, making it safer and more comfortable for patients. This approach could lead to quicker and more accurate adjustments in fluid therapy, potentially improving outcomes for patients with sepsis.

What evidence suggests that NICOM is effective for sepsis?

Research has shown that Non-Invasive Cardiac Output Monitoring (NICOM) is a helpful tool for managing fluid levels in patients with septic shock. In this trial, some participants will receive NICOM fluid assessment, which aids in treating patients with sepsis, a condition related to septic shock. NICOM measures blood flow changes, helping doctors determine the best way to restore fluids. This method accurately tracks key heart functions, such as the amount of blood the heart pumps with each beat. By using NICOM, doctors can better manage fluids and potentially reduce the risk of complications.12367

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+

Citations

Noninvasive cardiac output monitoring in septic shock patients

The overall mortality rate was 22%. NICOM is a valuable tool for guiding fluid resuscitation in septic shock patients.

Noninvasive cardiac output monitoring in septic... : Medicine

The overall mortality rate was 22%. NICOM is a valuable tool for guiding fluid resuscitation in septic shock patients.

Non-Invasive Cardiac Output Monitor (NICOM) for Goal ...

The aim is to pilot and evaluate the effectiveness of using The Non-Invasive Cardiac Output Monitor (NICOM) technology for goal-directed fluid ...

Accurate Non-invasive Cardiac Output Monitoring with ...

The study concluded that CO measured by Bioreactance produced acceptable accuracy, precision, and responsiveness in a wide range of circulatory situations.

Cardiac Output Monitoring Managing Intravenous Therapy ...

In this trial, we use the Non-Invasive Cardiac Output Monitor (NICOM), a noninvasive device that uses bioreactance (a methodology that measures phase shift ...

1595: noninvasive hemodynamic monitoring devices ... - Browse

Results: 69/69 (100%) hospitals completed the HMS spring 2024 survey. Of these, 17 (24.6%) reported using at least one non-invasive monitor, with 2/17 (11.7%) ...

NICOM for Septic Shock · Info for Participants

This trial tests a tool called the Non-Invasive Cardiac Output Monitor (NICOM) to assist doctors in determining fluid levels for patients with septic shock.