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Cardiac Output Monitor

NICOM for Septic Shock

N/A
Recruiting
Led By Jeffrey Dichter, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a non-invasive monitor to measure the need for fluid administration in sepsis patients, a more precise alternative to traditional single point readings.

Who is the study for?
This trial is for adult inpatients over 18 years old who have been hospitalized for at least 6 hours and are experiencing low blood pressure due to sepsis or have signs of septic shock, indicated by high lactate levels. It's not open to those who've opted out of research, patients expected to pass away within 24 hours, or those receiving end-of-life care within the first three days of hospitalization.
What is being tested?
The trial is testing NICOM technology which measures heart function non-invasively to guide fluid resuscitation in patients with hypotension or septic shock from sepsis. The goal is to see if this method can effectively determine when fluids should be given compared to older methods like CVP and PCWP measurements.
What are the potential side effects?
Since NICOM is a monitoring device rather than a drug, it doesn't have side effects like medications do. However, there may be discomfort associated with wearing the device or potential skin irritation from its sensors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been or will be admitted to the hospital for at least 6 hours.
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I have sepsis, indicated by very low blood pressure or high lactate levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Non-Invasive Cardiac Output Monitor (NICOM)Experimental Treatment1 Intervention
adult inpatients with sepsis associated with acute hypotension and/or evidence of septic shock
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NICOM
2014
N/A
~300

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,427 Previous Clinical Trials
1,619,697 Total Patients Enrolled
3 Trials studying Sepsis
367 Patients Enrolled for Sepsis
Jeffrey Dichter, MDPrincipal InvestigatorUniversity of Minnesota

Media Library

NICOM (Cardiac Output Monitor) Clinical Trial Eligibility Overview. Trial Name: NCT05630716 — N/A
NICOM (Cardiac Output Monitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630716 — N/A
Sepsis Research Study Groups: Non-Invasive Cardiac Output Monitor (NICOM)
Sepsis Clinical Trial 2023: NICOM Highlights & Side Effects. Trial Name: NCT05630716 — N/A
~389 spots leftby Nov 2025
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