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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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).

Eligibility

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.

Study details

Sepsis, Hypotension, Septic Shock

NCT05630716

University of Minnesota

25 January 2024

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