876 Participants Needed

NICOM for Septic Shock

JD
Overseen ByJeffrey Dichter, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is NICOM safe for use in humans?

NICOM, a non-invasive cardiac output monitor, has been used safely in various studies involving different patient groups, including critically ill patients, term infants, and those with pulmonary hypertension. While these studies primarily focus on its accuracy and feasibility, they do not report any significant safety concerns, suggesting it is generally safe for human use.12345

How is the NICOM treatment different from other treatments for septic shock?

NICOM is unique because it is a non-invasive method that continuously monitors cardiac output (the amount of blood the heart pumps) using bioreactance technology, which helps guide fluid management in patients with septic shock. Unlike other treatments, it does not require invasive procedures and can provide real-time data to assess fluid responsiveness.12346

What data supports the effectiveness of the treatment NICOM for septic shock?

Research suggests that NICOM, a non-invasive cardiac output monitor, can help manage fluid levels in patients with sepsis, which is related to septic shock. It has been used to predict disease severity and assess fluid responsiveness, which are important in treating septic shock.13678

Who Is on the Research Team?

JD

Jeffrey Dichter, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

You were admitted to the hospital and passed away within one day.
Opted out of having their medical information used in research, as noted in the EHR
You are receiving comfort care or have been admitted to hospice within the first 72 hours of being in the hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive goal-directed fluid resuscitation using the Non-Invasive Cardiac Output Monitor (NICOM) technology

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NICOM
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Non-Invasive Cardiac Output Monitor (NICOM)Experimental Treatment1 Intervention

NICOM is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Non-Invasive Cardiac Output Monitor for:
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Cheetah NICOM for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Published Research Related to This Trial

The NICO monitor, which uses a non-invasive method to measure cardiac output, showed a moderate correlation (0.691) with the standard thermodilution technique in a study of 12 patients who had cardiac surgery, indicating it can be a useful tool for monitoring cardiac output.
However, the NICO monitor produced lower cardiac output measurements compared to thermodilution, especially at higher output levels, and is best suited for patients who are not breathing spontaneously and can tolerate a slight increase in carbon dioxide levels.
Clinical evaluation of the non-invasive cardiac output (NICO) monitor in the intensive care unit.van Heerden, PV., Baker, S., Lim, SI., et al.[2022]
In a study of 50 adult emergency department patients at risk for sepsis, hemodynamic parameters from a non-invasive cardiac output monitor (NICOM) did not effectively predict disease severity or hospital admission compared to serum lactate levels.
Serum lactate was found to be a significantly better predictor of hospital admission and infection status, with an area under the ROC curve of 0.83, while cardiac output and other hemodynamic measures showed lower predictive values.
Early hemodynamic assessment using NICOM in patients at risk of developing Sepsis immediately after emergency department triage.Chukwulebe, SB., Gaieski, DF., Bhardwaj, A., et al.[2021]
The NICOM Cheetah monitor can reliably track changes in cardiac output during surgery, but calibration shifts can occur, especially during upper abdominal procedures, leading to unpredictable changes in readings of over 1 L/min/m.
In a study involving 36 patients undergoing various surgical interventions, it was found that while NICOM generally trends well with Doppler methods, significant calibration shifts were noted in 72% of patients during upper abdominal surgeries, indicating a need for caution when interpreting NICOM data in these situations.
Major Upper Abdominal Surgery Alters the Calibration of Bioreactance Cardiac Output Readings, the NICOM, When Comparisons Are Made Against Suprasternal and Esophageal Doppler Intraoperatively.Huang, L., Critchley, LAH., Zhang, J.[2022]

Citations

Clinical evaluation of the non-invasive cardiac output (NICO) monitor in the intensive care unit. [2022]
Early hemodynamic assessment using NICOM in patients at risk of developing Sepsis immediately after emergency department triage. [2021]
Major Upper Abdominal Surgery Alters the Calibration of Bioreactance Cardiac Output Readings, the NICOM, When Comparisons Are Made Against Suprasternal and Esophageal Doppler Intraoperatively. [2022]
Ultrasound and NICOM in the assessment of fluid responsiveness in patients with mild sepsis in the emergency department: a pilot study. [2019]
Accuracy assessment of noninvasive cardiac output monitoring in the hemodynamic monitoring in critically ill patients. [2021]
Feasibility of non-invasive cardiac output monitoring at birth using electrical bioreactance in term infants. [2021]
Noninvasive cardiac output measurements in patients with pulmonary hypertension. [2021]
Non-invasive cardiac output monitoring in neonates using bioreactance: a comparison with echocardiography. [2019]
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