Recruiting

NICOM

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT07779720

Conditions

Sepsis

Septic Shock

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Invasive Cardiac Output Monitoring (NICOM)

Study Details

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

Study ID

NCT07779720

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult patient being treated in the Intermountain Medical Center ED
2. 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
3. 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.

Exclusion Criteria:

1. Age < 18 years
2. Known pregnant patients
3. Patients who are known to be incarcerated
4. A trained and delegated study team member is not available to perform the NICOM fluid assessment
5. Patient has been in the ED for >6 hours or was transferred from an outside ED
6. 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
7. Known clinical diagnosis of a condition potentially altering risk/benefit profile of NICOM-based fluid assessment, which may include

1. Hemorrhagic shock (i.e.., active hemorrhage)
2. Cardiogenic shock (i.e., hypotension suspected to be due to left or right ventricular failure)
3. Obstructive shock (i.e., shock in the setting of known acute central pulmonary embolism, pneumothorax, or pericardial effusion)
4. Active volume loss that requires fluid replacement per the treating clinician (i.e., injury due to burn)
5. Acute stroke
6. Acute myocardial infarction
7. Status asthmaticus
8. Status epilepticus
9. Presence of a left ventricular assist device (LVAD)
10. Severe aortic insufficiency
8. Known clinical contraindication to passive leg raise.

1. Lower extremity amputation
2. Lower extremity trauma
3. Open abdomen
4. Suspected or known elevated intracranial pressure, for example from intracranial hemorrhage, tumor, or traumatic brain injury
5. Contraindication to lying flat
6. Inability to cooperate with the maneuver (e.g., severe pain, agitation).
9. Contraindication to non-invasive cardiac output monitoring (NICOM) lead placement.

1. Allergy to adhesive used in the NICOM lead stickers
2. Skin breakdown precluding lead placement on the patient's chest and back
10. Treating clinician determines that NICOM assessment is either required or contraindicated for the optimal care of the patient

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: NICOM Fluid Assessment

NICOM fluid assessment

no intervention: Usual Care

Participants will not receive any research intervention

Interventions

Non-Invasive Cardiac Output Monitoring (NICOM)

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

Primary outcome measure

  • IV fluid volume (3-hour) [ Time Frame: 3 hours ]

Central Contacts and Locations

Central contacts

Locations

Intermountain Medical Center Emergency Department

Recruiting

Murray, Utah, United States, 84107

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Sepsis
  • septic shock

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2026-08-25.