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

NCT ID: NCT05630716

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2025-05-31

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).

Conditions

Sepsis; Hypotension; Septic Shock

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Non-Invasive Cardiac Output Monitor (NICOM)

adult inpatients with sepsis associated with acute hypotension and/or evidence of septic shock

Group Type: EXPERIMENTAL

NICOM

Intervention Type: DEVICE

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.

Interventions

NICOM

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Dichter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

MEDICAL PROTOCOL

Identifier Type: -

Identifier Source: org_study_id