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

NCT05630716 | Completed

• 1 other identifier: MEDICAL PROTOCOL
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Hospital mortality

  18 months post-treatment

• Hospital length of stay

  18 months post-treatment

• ICU length of stay

  18 months post-treatment

Secondary Outcomes (3)

• 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)

Study Arms (1)

Non-Invasive Cardiac Output Monitor (NICOM)

EXPERIMENTAL

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

Device: NICOM

Interventions

NICOM 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.

Non-Invasive Cardiac Output Monitor (NICOM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Sepsis; Hypotension; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Shock

Study Officials

• Jeffrey Dichter, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 30, 2022
• Study Start: July 31, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)