Hypotension, Sepsis, Septic Shock
Conditions
Brief summary
The Non-Invasive Cardiac Output Monitor (NICOM) is a non-invasive monitor capable of measuring cardiac output (CO) and cardiac index (CI), and stroke volume (SV) and stroke volume index (SVI) based on heart rate. Conceptually NICOM is a technology that utilizes a dynamic response characteristic in assessing the need for fluid administration, whereby SVI is measured before and after a fluid challenge with more fluid given only if SVI increases significantly with administered fluid. Dynamic response technologies are intended to replace older, static measures such as central venous pressure (CVP) and pulmonary capillary wedge pressures (PCWP) which are single point measurements utilized to assess the need to administer fluid. The aim is to pilot and evaluate the effectiveness of using The Non-Invasive Cardiac Output Monitor (NICOM) technology for goal-directed fluid resuscitation in adult inpatients with sepsis associated acute hypotension and/or evidence of septic shock (Lactate \>= 4.0).
Interventions
DEVICENICOM
non-invasive monitor capable of measuring cardiac output (CO) and cardiac index (CI), and stroke volume (SV) and stroke volume index (SVI) based on heart rate. The NICOM technology will be implemented by the Rapid Response Team providers (Advanced Practice Providers) and ICU nurses at FSH, most of whom are already trained and familiar with its use.
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients \> 18 years of age * inpatients for \>/= 6 hours * meeting criteria for sepsis as defined by hypotension related to sepsis (MAP \< 65 or SBP \< 90) or evidence of septic shock (Lactate ≥ 4.0).
Exclusion criteria
* Patients who die within 24 hours of hospital admission * patients documented as comfort cares or enrolled in general inpatient hospice during the first 72 hours of hospitalization. * opted out of having their medical information used in research, as noted in the EHR.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital mortality | 18 months post-treatment |
| Hospital length of stay | 18 months post-treatment |
| ICU length of stay | 18 months post-treatment |
Secondary
| Measure | Time frame |
|---|---|
| Hours of vasopressor use | 18 months post-treatment |
| change from baseline serum creatinine | 18 months post-treatment |
| Difference in positive fluid balance at 75 hours of ICU discharge | 75 hours post treatment ( ICU discharge) |
Countries
United States
Outcome results
None listed