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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05630716
• Other study ID #: MEDICAL PROTOCOL
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: July 2023
• Source: University of Minnesota
• Contact: Jeffrey Dichter, MD
• Phone: 612-624-0999
• Email: jdichter[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 876
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Hypotension
• Sepsis
• Septic Shock
• Shock
• Shock, Septic

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital mortality		18 months post-treatment
Primary	Hospital length of stay		18 months post-treatment
Primary	ICU length of stay		18 months post-treatment
Secondary	Hours of vasopressor use		18 months post-treatment
Secondary	change from baseline serum creatinine		18 months post-treatment
Secondary	Difference in positive fluid balance at 75 hours of ICU discharge		75 hours post treatment ( ICU discharge)