← Back to Search

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
All adult patients > 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months post-treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have been or will be admitted to the hospital for at least 6 hours.
Select...
I am over 18 years old.
Select...
I have sepsis, indicated by very low blood pressure or high lactate levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hospital length of stay
Hospital mortality
ICU length of stay
Secondary outcome measures
Difference in positive fluid balance at 75 hours of ICU discharge
Hours of vasopressor use
change from baseline serum creatinine

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
1,371 Previous Clinical Trials
1,587,206 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment presently accepting participants?

"According to the clinical trials directory, this medical trial is not presently recruiting for participants. Posting on January 1st 2023 with its most recent update being November 26th 2022, there are no longer any open slots available in this study - however, 397 other studies have opened their enrolment process."

Answered by AI
~584 spots leftby Nov 2025