NCT07779720 · Intermountain Health Care, Inc.
Personalized Fluid Resuscitation in the Emergency Department: A Pilot Trial
(FLUID-ED)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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 measures
IV fluid volume (3-hour)
Time frame: 3 hours
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Presence of a left ventricular assist device (LVAD)
- Severe aortic insufficiency
- Known clinical contraindication to passive leg raise.
- Lower extremity amputation
- Lower extremity trauma
- Open abdomen
- Suspected or known elevated intracranial pressure, for example from intracranial hemorrhage, tumor, or traumatic brain injury
- Contraindication to lying flat
- Inability to cooperate with the maneuver (e.g., severe pain, agitation).
- Contraindication to non-invasive cardiac output monitoring (NICOM) lead placement.
- Allergy to adhesive used in the NICOM lead stickers
- Skin breakdown precluding lead placement on the patient's chest and back
- Treating clinician determines that NICOM assessment is either required or contraindicated for the optimal care of the patient
Where
- Murray, Utah
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 25, 2026 · Source of record for eligibility and locations