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

Primary Purpose

Sepsis, Hypotension, Septic Shock

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NICOM
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-Invasive Cardiac Output Monitor (NICOM)

Arm Description

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

Outcomes

Primary Outcome Measures

Hospital mortality
Hospital length of stay
ICU length of stay

Secondary Outcome Measures

Hours of vasopressor use
change from baseline serum creatinine
Difference in positive fluid balance at 75 hours of ICU discharge

Full Information

First Posted
November 8, 2022
Last Updated
July 31, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05630716
Brief Title
Non-Invasive Cardiac Output Monitor (NICOM) for Goal-directed Fluid Resuscitation for Inpatients With Hypotension and/or Septic Shock
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Hypotension, Septic Shock

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
876 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-Invasive Cardiac Output Monitor (NICOM)
Arm Type
Experimental
Arm Description
adult inpatients with sepsis associated with acute hypotension and/or evidence of septic shock
Intervention Type
Device
Intervention Name(s)
NICOM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital mortality
Time Frame
18 months post-treatment
Title
Hospital length of stay
Time Frame
18 months post-treatment
Title
ICU length of stay
Time Frame
18 months post-treatment
Secondary Outcome Measure Information:
Title
Hours of vasopressor use
Time Frame
18 months post-treatment
Title
change from baseline serum creatinine
Time Frame
18 months post-treatment
Title
Difference in positive fluid balance at 75 hours of ICU discharge
Time Frame
75 hours post treatment ( ICU discharge)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Dichter, MD
Phone
612-624-0999
Email
jdichter@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Dichter, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Dichter, MD
Phone
612-624-0999

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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