An interventional study of Non-Invasive Cardiac Output Monitoring (NICOM) in Sepsis and Septic Shock, sponsored by Intermountain Health Care, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Intermountain Health Care, Inc. · Not applicable, Interventional, and Treatment
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.
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).
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 40 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Intermountain Health Care, Inc. is the lead sponsor of 120 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Known clinical diagnosis of a condition potentially altering risk/benefit profile of NICOM-based fluid assessment, which may include
Known clinical to passive leg raise.
Contraindication to non-invasive cardiac output monitoring (NICOM) lead placement.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NICOM fluid assessment
Other: Non-Invasive Cardiac Output Monitoring (NICOM)
Participants will not receive any research intervention
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
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).
Time frame: 3 hours
Sepsis bundle compliance (3-hour)
Compliance with SEP-1 sepsis 3-hour bundle
Time frame: 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.
Time frame: Day 1
Sepsis bundle compliance (6-hour)
Compliance with SEP-1 sepsis 6-hour bundle
Time frame: 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.
Time frame: Day 1
IV Fluid Volume (6 hour)
Volume of IV resuscitative fluids (as defined in the primary outcome) given within 6 hours of enrollment
Time frame: 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).
Time frame: Day 1
ICU admission (safety)
Admission to the ICU
Time frame: Study day 1
Oxygen requirement (safety)
Highest oxygen requirement (maximum FiO2)
Time frame: Study Day 1, Study Day 2
Diuresis (safety)
Need for IV diuresis
Time frame: through Study Day 2
Plan to share: Undecided — De-identified dataset will be made available in accordance with IRB and site regulations.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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