Non-Invasive Cardiac Output Monitor (NICOM) for Goal-directed Fluid Resuscitation for Inpatients With Hypotension and/or Septic Shock

Study Overview
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Brief Summary
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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).

Official Title
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Pilot Evaluation Using The Non-Invasive Cardiac Output Monitor (NICOM) for Goal-directed Fluid Resuscitation for Inpatients With Hypotension and/or Septic Shock

Conditions
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Sepsis, Hypotension, Septic Shock

Intervention / Treatment
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* Device: NICOM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-Invasive Cardiac Output Monitor (NICOM)<br>adult inpatients with sepsis associated with acute hypotension and/or evidence of septic shock | Device: NICOM<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) |