Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the impact that the Venus 1000 non-invasive CVP system has on the management of emergency department (ED) patients with fluid sensitive conditions.

Detailed Description
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The ability to non-invasively, accurately, and continuously measure CVP to assess the preload status of ED patients could lead to its inclusion into existing protocols (similar to EGDT), or the development of novel protocols for the treatment of patients with fluid sensitive conditions. The majority of other non-invasive measures of preload, such as ultrasound of the inferior vena cava or the passive leg raise technique are not continuous measures and require some type of effort or skill on the part of the clinician. Continuous methods of assessing preload include CVP measurement through a central venous catheter, esophageal Doppler monitoring, and pulse contour analysis via arterial catheter monitoring, all of which involve invasive procedures. The Venus CVP device is non-invasive and has continuous monitoring capabilities. The data acquired from this project will allow us to determine whether emergency physicians will, in practice, utilize the information provided by a non-invasive CVP monitoring device to assist in the management of their patients with severe sepsis or acute HF.

Official Title
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Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial

Conditions
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Severe Sepsis, Acute Heart Failure

Intervention / Treatment
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* Device: Mespere Venus 1000 Non-Invasive CVP System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years old or greater English speaking Clinical diagnosis of: 1) Severe Sepsis, or 2) Acute Heart Failure Exclusion Criteria: Traumatic injuries Active bleeding Pregnancy Prisoners Central venous catheter placement in the internal jugular or subclavian veins Bilateral external jugular vein catheterizations Concurrent enrollment into an interventional clinical trial that may affect subject treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open physician access to Venus 1000 CVP data<br> | Device: Mespere Venus 1000 Non-Invasive CVP System<br>* The Venus 1000 CVP System is a non-invasive central venous pressure measurement system that utilizes the proven science of NIRS. Approved by FDA, received Health Canada Medical Device Licence and CE Marked, the Venus 1000 has been proven to be clinically equivalent to measurements made via right heart catheterization.<br>|
| Other: No open physician access to Venus 1000 CVP data<br> | Device: Mespere Venus 1000 Non-Invasive CVP System<br>* The Venus 1000 CVP System is a non-invasive central venous pressure measurement system that utilizes the proven science of NIRS. Approved by FDA, received Health Canada Medical Device Licence and CE Marked, the Venus 1000 has been proven to be clinically equivalent to measurements made via right heart catheterization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day Readmission |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of IV fluid administered over hospitalization |  | 30 days | 
| Dose, timing and duration of all IV vasoactive medications |  | 30 days | 
| Length of stay in hospital |  | 30 days | 
| Duration of respiratory support |  | 30 days | 
| Rapid response activations |  | 30 days | 
| Mortality (in hospital, 7-day, 30-day) |  | 30 days | 
| Number of repeat ED visits through 30 days post-discharge |  | 30 days |