Can a simple leg raise guide sepsis fluid treatment?

NCT ID NCT07779720

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Intermountain Medical Center Emergency Department

    RECRUITING

    Murray, Utah, 84107, United States

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