SepsisFLUID-EDNCT07779720
Personalized Fluid Resuscitation in the Emergency Department: A Pilot Trial
A study testing Non-Invasive Cardiac Output Monitoring (NICOM) in people with Sepsis and Septic Shock, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Non-Invasive Cardiac Output Monitoring (NICOM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Intermountain Medical Center Emergency Department
Murray, Utah, 84107
About this study
Official title: Personalized Fluid Resuscitation for Improved Sepsis Resuscitation Quality in the Emergency Department
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.
Read the detailed description
We will conduct a single-center pilot feasibility trial comparing a dynamic fluid assessment using non-invasive cardiac output monitoring (NICOM) vs usual care in 40 patients with sepsis in the Emergency Department (ED). The trial will enroll patients with suspected sepsis and hypotension or lactate ≥4 mmol/L who have not received 30 ml/kg initial IV fluid. Patients will be randomized 3:1 to receive a NICOM fluid assessment vs standard care. The NICOM fluid assessment will involve measuring stroke volume change during a passive leg raise using NICOM. Results will be provided to the ED treating team. The primary outcome will be IV fluid received within 3 hours. Secondary outcomes include sepsis bundle compliance and feasibility and acceptability of the NICOM assessment (assessed via clinician survey).
- Conditions
- Sepsis, Septic Shock
- Being tested
- Non-Invasive Cardiac Output Monitoring (NICOM)
- Keywords
- Sepsis, septic shock
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Cardiac Output Monitoring (NICOM)Other
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| NICOM Fluid Assessment | Active comparator | NICOM fluid assessment Receives: Other: Non-Invasive Cardiac Output Monitoring (NICOM) |
| Usual Care | No intervention | Participants will not receive any research intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 hours
Secondary outcomes (6)
Sepsis bundle compliance (3-hour)
Compliance with SEP-1 sepsis 3-hour bundle
Measured: 3 hours
Feasibility
Feasibility of the intervention to ED teams. Feasibility will be measured through a survey of ED nurses caring for patients in the trial using an adapted Feasibility of Intervention Measure (FIM), scored on a 1-5 scale with 5 indicating highest feasibility.
Measured: Day 1
Sepsis bundle compliance (6-hour)
Compliance with SEP-1 sepsis 6-hour bundle
Measured: 6 hours
Acceptability
Acceptability of intervention to the ED clinician. This outcome will be assessed through a survey of physicians and advanced practice providers caring for patients in the trial and will be measured on an adapted Acceptability of Intervention Measure (AIM), scored 1 to 5 with higher scores indicating higher acceptability.
Measured: Day 1
IV Fluid Volume (6 hour)
Volume of IV resuscitative fluids (as defined in the primary outcome) given within 6 hours of enrollment
Measured: 6 hours
Utility of intervention
Utility of intervention for ED fluid decision-making, assessed by survey of ED physicians/advanced practice providers caring for patients in the trial using self-reported assessments of whether the NICOM assessment results changed fluid management plans (yes/no) and whether the results were helpful for clinical decision making (1-5 scale, with 5 indicating more utility).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start26 Aug 2026
- Primary completionJan 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot trial comparing NICOM fluid assessment vs usual care
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779720
- Sponsor's protocol ID
- 1035851
- Acronym
- FLUID-ED
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified dataset will be made available in accordance with IRB and site regulations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Fluid Resuscitation for Improved Sepsis Resuscitation Quality in the Emergency Department
- ClinicalTrials.gov ID
- NCT07779720
- Acronym / sponsor ID
- FLUID-ED / 1035851
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, septic shock
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We will conduct a single-center pilot feasibility trial comparing a dynamic fluid assessment using non-invasive cardiac output monitoring (NICOM) vs usual care in 40 patients with sepsis in the Emergency Department (ED). The trial will enroll patients with suspected sepsis and hypotension or lactate ≥4 mmol/L who have not received 30 ml/kg initial IV fluid. Patients will be randomized 3:1 to receive a NICOM fluid assessment vs standard care. The NICOM fluid assessment will involve measuring stroke volume change during a passive leg raise using NICOM. Results will be provided to the ED treating team. The primary outcome will be IV fluid received within 3 hours. Secondary outcomes include sepsis bundle compliance and feasibility and acceptability of the NICOM assessment (assessed via clinician survey).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot trial comparing NICOM fluid assessment vs usual care
| Arm | Type | Receives |
|---|---|---|
| NICOM Fluid Assessment | Active comparator | Other: Non-Invasive Cardiac Output Monitoring (NICOM)NICOM fluid assessment |
| Usual Care | No intervention | –Participants will not receive any research intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Invasive Cardiac Output Monitoring (NICOM)Also: NICOMTrained 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 | Other | NICOM Fluid Assessment |
Primary outcome
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).
6 secondary outcomes
Sepsis bundle compliance (3-hour)
Time frame: 3 hours
Feasibility
Time frame: Day 1
Sepsis bundle compliance (6-hour)
Time frame: 6 hours
Acceptability
Time frame: Day 1
IV Fluid Volume (6 hour)
Time frame: 6 hours
Utility of intervention
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided. De-identified dataset will be made available in accordance with IRB and site regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Cardiac Output Monitoring (NICOM) in people with Sepsis and Septic Shock, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Munroe, MD (801-408-1991, elizabeth.munroe@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IV fluid volume (3-hour) (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.