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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Non-Invasive Cardiac Output Monitoring (NICOM)
Other interventionTrained 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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: NICOM Fluid AssessmentActive comparator 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 hoursSecondary outcomes
1
Sepsis bundle compliance (3-hour)
Compliance with SEP-1 sepsis 3-hour bundle
Time frame
3 hours2
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 13
Sepsis bundle compliance (6-hour)
Compliance with SEP-1 sepsis 6-hour bundle
Time frame
6 hours4
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 1Other outcomes
1
ICU admission (safety)
Admission to the ICU
Time frame
Study day 12
Oxygen requirement (safety)
Highest oxygen requirement (maximum FiO2)
Time frame
Study Day 1, Study Day 23
Diuresis (safety)
Need for IV diuresis
Time frame
through Study Day 2Sponsors and contacts
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Source ClinicalTrials.gov