NICOM for Septic Shock

Overseen By Jeffrey Dichter, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Comfort care, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

876 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{3 5 6 7 8}

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. ^{3 4 5 6 7}

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).

Research Team

Jeffrey Dichter, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Non-Invasive Cardiac Output Monitor (NICOM) Experimental Treatment 1 Intervention

adult inpatients with sepsis associated with acute hypotension and/or evidence of septic shock

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

Approved in United States as Non-Invasive Cardiac Output Monitor for:

• Monitoring cardiac output in critically ill patients
• Goal-directed fluid resuscitation in septic shock

Approved in European Union as Cheetah NICOM for:

• Non-invasive hemodynamic monitoring in critical care settings
• Fluid management in sepsis and shock

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a pilot study of 37 sepsis patients, combining the caval index and Noninvasive Cardiac Output Monitoring (NICOM) helped determine that at least 1000 mL of saline is necessary to significantly increase stroke volume in patients with a high caval index, while 500 mL was insufficient.

The study found no signs of fluid overload in any patients, suggesting that this fluid management approach is safe and may be beneficial in emergency settings for treating sepsis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound and NICOM in the assessment of fluid responsiveness in patients with mild sepsis in the emergency department: a pilot study. Oord, M., Olgers, TJ., Doff-Holman, M., et al.[2019]

In a study involving 98 critically ill patients, cardiac output measurements from noninvasive cardiac output monitoring (NICOM) were found to be consistent with those obtained from ultrasound and pulse index continuous cardiac output (PiCCO), indicating that NICOM is a reliable method for hemodynamic monitoring.

The stroke volume index variation (∆SVI) calculated using NICOM's passive leg raising test effectively predicted volume responsiveness in patients with noncardiogenic circulatory shock, with a sensitivity of 88.37% and a specificity of 52.94%, demonstrating its clinical utility in managing fluid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy assessment of noninvasive cardiac output monitoring in the hemodynamic monitoring in critically ill patients. Zhu, G., Zhang, K., Fu, Y., et al.[2021]

The study measured cardiac output in 49 term infants using a non-invasive NICOM device at birth and 2 hours after birth, finding a significant decrease in cardiac output from 101 mL/kg/min at birth to 89 mL/kg/min at 2 hours (p<0.001).

The NICOM technique was found to be safe with no adverse effects reported, indicating its feasibility for monitoring cardiac output in newborns during delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of non-invasive cardiac output monitoring at birth using electrical bioreactance in term infants. McCarthy, KN., Pavel, A., Garvey, AA., et al.[2021]

In a study of 50 patients with pulmonary hypertension, the NICOM® device provided more precise cardiac output measurements compared to traditional methods like thermodilution and Fick, with a coefficient of variation of 3.5% for NICOM versus 9.6% for thermodilution.

NICOM was able to reliably detect changes in cardiac output in response to vasodilator challenges, suggesting it could be a valuable noninvasive tool for monitoring patients with pulmonary hypertension and assessing their treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive cardiac output measurements in patients with pulmonary hypertension. Rich, JD., Archer, SL., Rich, S.[2021]

The NICOM™ method for non-invasive cardiac output monitoring in neonates shows strong correlation with echocardiography measurements, indicating it can be a reliable tool for assessing cardiac function in this vulnerable population.

However, NICOM consistently underestimates left ventricular output compared to echocardiography, suggesting that while it is feasible, further validation is needed before it can be used routinely in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive cardiac output monitoring in neonates using bioreactance: a comparison with echocardiography. Weisz, DE., Jain, A., McNamara, PJ., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the non-invasive cardiac output (NICO) monitor in the intensive care unit. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Early hemodynamic assessment using NICOM in patients at risk of developing Sepsis immediately after emergency department triage. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

Ultrasound and NICOM in the assessment of fluid responsiveness in patients with mild sepsis in the emergency department: a pilot study. [2019]

5. China pubmed.ncbi.nlm.nih.gov

Accuracy assessment of noninvasive cardiac output monitoring in the hemodynamic monitoring in critically ill patients. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Feasibility of non-invasive cardiac output monitoring at birth using electrical bioreactance in term infants. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Noninvasive cardiac output measurements in patients with pulmonary hypertension. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Non-invasive cardiac output monitoring in neonates using bioreactance: a comparison with echocardiography. [2019]