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.
We will conduct a single-center pilot feasibility trial comparing a dynamic fluid assessment using non-invasive cardiac output monitoring (NICOM) vs usual care in 40 patients with sepsis in the Emergency Department (ED). The trial will enroll patients with suspected sepsis and hypotension or lactate ≥4 mmol/L who have not received 30 ml/kg initial IV fluid. Patients will be randomized 3:1 to receive a NICOM fluid assessment vs standard care. The NICOM fluid assessment will involve measuring stroke volume change during a passive leg raise using NICOM. Results will be provided to the ED treating team. The primary outcome will be IV fluid received within 3 hours. Secondary outcomes include sepsis bundle compliance and feasibility and acceptability of the NICOM assessment (assessed via clinician survey).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Trained 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
Intermountain Medical Center Emergency Department
Murray, Utah, United States
RECRUITINGIV 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 hours
Sepsis bundle compliance (3-hour)
Compliance with SEP-1 sepsis 3-hour bundle
Time frame: 3 hours
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 1
Sepsis bundle compliance (6-hour)
Compliance with SEP-1 sepsis 6-hour bundle
Time frame: 6 hours
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 1
IV Fluid Volume (6 hour)
Volume of IV resuscitative fluids (as defined in the primary outcome) given within 6 hours of enrollment
Time frame: 6 hours
Utility of intervention
Utility of intervention for ED fluid decision-making, assessed by survey of ED physicians/advanced practice providers caring for patients in the trial using self-reported assessments of whether the NICOM assessment results changed fluid management plans (yes/no) and whether the results were helpful for clinical decision making (1-5 scale, with 5 indicating more utility).
Time frame: Day 1
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