Pilot Evaluation Using The Non-Invasive Cardiac Output Monitor (NICOM) for Goal-directed Fluid Resuscitation for Inpatients With Hypotension and/or Septic Shock
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 251
- Locations
- 2
- Primary Endpoint
- ICU length of stay
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
ICU length of stay
Time Frame: 18 months post-treatment
Hospital length of stay
Time Frame: 18 months post-treatment
Hospital mortality
Time Frame: 18 months post-treatment
Secondary Outcomes
- Difference in positive fluid balance at 75 hours of ICU discharge(75 hours post treatment ( ICU discharge))
- Hours of vasopressor use(18 months post-treatment)
- change from baseline serum creatinine(18 months post-treatment)