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

University of Minnesota (UMN)

Status

Enrolling

Conditions

Hypotension

Septic Shock

Sepsis

Treatments

Device: NICOM

Study type

Interventional

Funder types

Other

Identifiers

NCT05630716

MEDICAL PROTOCOL

Details and patient eligibility

About

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).

Enrollment

876 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.