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

Not Applicable

Recruiting

• Conditions: Sepsis; Hypotension; Septic Shock
• Interventions: Device: NICOM

• Registration Number: NCT05630716
• Lead Sponsor: University of Minnesota

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-26
• Study First Posted: 2022-11-30
• Study Start: 2023-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 876

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-Invasive Cardiac Output Monitor (NICOM)	NICOM	adult inpatients with sepsis associated with acute hypotension and/or evidence of septic shock

Primary Outcome Measures

Name	Time	Method
Hospital length of stay	18 months post-treatment
Hospital mortality	18 months post-treatment
ICU length of stay	18 months post-treatment

Secondary Outcome Measures

Name	Time	Method
Difference in positive fluid balance at 75 hours of ICU discharge	75 hours post treatment ( ICU discharge)
Hours of vasopressor use	18 months post-treatment
change from baseline serum creatinine	18 months post-treatment

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States