Personalized Fluid Resuscitation in the Emergency Department

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center pilot feasibility trial compares NICOM-guided fluid assessment to usual care in 40 adults with suspected sepsis and hypotension or high lactate in the ED. Participants are randomized 3:1 to receive a one-time NICOM assessment of fluid responsiveness during a passive leg raise, with results shared with the treating team in addition to standard care. The primary outcome is the total IV fluid given within 3 hours, while secondary outcomes include sepsis bundle adherence and the feasibility and acceptability of NICOM use as measured by clinician surveys. The study aims to determine whether NICOM can influence fluid resuscitation decisions and is practical for ED workflow. All participants receive standard medical care alongside the NICOM intervention when assigned.

Why it matters

Who can join: the full rules

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

Where it's running

• Intermountain Medical Center Emergency Department
  Murray, Utah, United States Recruiting

Study contacts

• Study coordinator: Elizabeth Munroe, MD
• Email: elizabeth.munroe@imail.org
• Phone: 801-408-1991

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.