Sepsis, Septic Shock
Conditions
Keywords
Sepsis, septic shock
Brief summary
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.
Detailed description
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).
Interventions
OTHERNon-Invasive Cardiac Output Monitoring (NICOM)
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
Sponsors
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot trial comparing NICOM fluid assessment vs usual care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IV fluid volume (3-hour) | 3 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sepsis bundle compliance (3-hour) | 3 hours | Compliance with SEP-1 sepsis 3-hour bundle |
| Feasibility | Day 1 | 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. |
| Sepsis bundle compliance (6-hour) | 6 hours | Compliance with SEP-1 sepsis 6-hour bundle |
| Acceptability | Day 1 | 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. |
| IV Fluid Volume (6 hour) | 6 hours | Volume of IV resuscitative fluids (as defined in the primary outcome) given within 6 hours of enrollment |
| Utility of intervention | Day 1 | 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). |
Countries
United States
Contacts
CONTACTElizabeth Munroe, MD
Outcome results
None listed