Can a simple leg raise guide sepsis fluid treatment?
NCT ID NCT07779720
First seen Aug 21, 2026 · Last updated Aug 26, 2026 · Updated 2 times
Summary
This pilot trial explores whether a non-invasive cardiac output monitor (NICOM) can help guide fluid resuscitation in emergency department patients with sepsis and low blood pressure. Participants receive standard care, and some also undergo a one-time NICOM assessment that includes a passive leg raise to see if their body responds to fluids. The study measures whether this assessment changes the amount of IV fluids given within three hours and whether it is feasible and acceptable in a busy ED setting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Non-invasive cardiac output monitoring (NICOM) fluid assessment
- What this could lead to
- If effective, this approach could improve how fluids are given to sepsis patients, potentially leading to better outcomes and more personalized emergency care.
- What could go wrong
- This is a small pilot study, so results may not apply broadly. The intervention is only a one-time assessment, and its impact on long-term outcomes is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Intermountain Medical Center Emergency Department
RECRUITINGMurray, Utah, 84107, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Persistent inflammation, immunosuppression and catabolism syndrome (PICS): a new horizon for surgical critical care subtitle: cardiac dysfunction in older sepsis survivors subtitle: development of a designer Proline-Rich antimicrobial peptide chaperone protein inhibitor (DPC) for treating sepsis
- A randomized clinical trial of early empiric Anti-Mycobacterium tuberculosis therapy for sepsis in Sub-Saharan africa
- Tracing of real-time glu13Cose metabolism in human immune cells - intensive care unit
- Can a blood filter strip away toxins in septic shock?
- Could a neck vein check replace a harder ultrasound for ICU fluid management?
- Sepsis alert system aims to speed up critical care response in hospitals