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Completed

NCT Number: NCT05630716

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Hospital mortality

    Time frame: 18 months post-treatment

  2. Hospital length of stay

    Time frame: 18 months post-treatment

  3. ICU length of stay

    Time frame: 18 months post-treatment

Secondary outcomes

  1. Hours of vasopressor use

    Time frame: 18 months post-treatment

  2. change from baseline serum creatinine

    Time frame: 18 months post-treatment

  3. Difference in positive fluid balance at 75 hours of ICU discharge

    Time frame: 75 hours post treatment ( ICU discharge)

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 30, 2022
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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