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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
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months post-treatment
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You were admitted to the hospital and passed away within one day.I have been or will be admitted to the hospital for at least 6 hours.You are receiving comfort care or have been admitted to hospice within the first 72 hours of being in the hospital.I am over 18 years old.I have sepsis, indicated by very low blood pressure or high lactate levels.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Non-Invasive Cardiac Output Monitor (NICOM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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."
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