Personalized Fluid Resuscitation in the Emergency Department: A Pilot Trial

NCT07779720 | Recruiting DMC

• 1 other identifier: 1035851
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis; Septic Shock

Keywords

Sepsis; septic shock

Outcome Measures

Primary Outcomes (1)

• IV fluid volume (3-hour)

  Total volume of IV resuscitative fluids received within 3 hours of enrollment. This will be measured as total volume and as a weight-based measure in mL/kg (using actual weight up to BMI 30 and ideal body weight for patients with BMI \>=30).

  3 hours

Secondary Outcomes (6)

• Sepsis bundle compliance (3-hour)

  3 hours

• Feasibility

  Day 1

• Sepsis bundle compliance (6-hour)

  6 hours

• Acceptability

  Day 1

• IV Fluid Volume (6 hour)

  6 hours

Other Outcomes (3)

• ICU admission (safety)

  Study day 1

• Oxygen requirement (safety)

  Study Day 1, Study Day 2

• Diuresis (safety)

  through Study Day 2

Study Arms (2)

NICOM Fluid Assessment

ACTIVE COMPARATOR

NICOM fluid assessment

Other: Non-Invasive Cardiac Output Monitoring (NICOM)

Usual Care

NO INTERVENTION

Participants will not receive any research intervention

Interventions

Non-Invasive Cardiac Output Monitoring (NICOM) OTHER

Trained study team members will perform a NICOM fluid assessment. This assessment involves performing a passive leg raise while measuring change in stroke volume (SV) with the non-invasive cardiac output monitor (NICOM). A SV change \>=10% during the passive leg raise indicates a patient is fluid responsive. The results of the NICOM fluid assessment will be provided to the patient's treating physician

Also known as: NICOM

NICOM Fluid Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient being treated in the Intermountain Medical Center ED
• Patient has suspected sepsis. Suspected sepsis can be identified by a positive sepsis screen (standard screen completed by ED triage nurse), an active sepsis alert (which is triggered based on qualifying information or active by an ED nurse), or clinician report that patient has possible sepsis
• Patient is hypotensive OR has an initial lactate ≥4 mmol/L at the time of enrollment. Hypotension is defined as mean arterial pressure (MAP) \<65 mmHg or systolic blood pressure (SBP) \<90mmHg or patient is on vasopressors at time of enrollment.

You may not qualify if:

• Age \< 18 years
• Known pregnant patients
• Patients who are known to be incarcerated
• A trained and delegated study team member is not available to perform the NICOM fluid assessment
• Patient has been in the ED for \>6 hours or was transferred from an outside ED
• Patient has already received 30 ml/kg IV fluid or has this fluid volume ordered. Weight-based fluid dosing is calculated based on actual body weight for BMI \<30kg/m2 and ideal body weight for BMI ≥30 kg/m2
• Known clinical diagnosis of a condition potentially altering risk/benefit profile of NICOM-based fluid assessment, which may include
• Hemorrhagic shock (i.e.., active hemorrhage)
• Cardiogenic shock (i.e., hypotension suspected to be due to left or right ventricular failure)
• Obstructive shock (i.e., shock in the setting of known acute central pulmonary embolism, pneumothorax, or pericardial effusion)
• Active volume loss that requires fluid replacement per the treating clinician (i.e., injury due to burn)
• Acute stroke
• Acute myocardial infarction
• Status asthmaticus
• Status epilepticus

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center Emergency Department

Murray, Utah, 84107, United States

RECRUITING

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Elizabeth Munroe, MD

CONTACT

801-408-1991; elizabeth.munroe@imail.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot trial comparing NICOM fluid assessment vs usual care

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

US (1)