Personalized Fluid Resuscitation in the Emergency Department: A Pilot Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIntermountain Health Care, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Non-Invasive Cardiac Output Monitoring (NICOM)
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov