Acute Heart Failure, Severe Sepsis
Conditions
Brief summary
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
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.
Interventions
DEVICEMespere Venus 1000 Non-Invasive CVP System
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.
Sponsors
Wayne State University
Mespere Lifesciences Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day Readmission | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Dose, timing and duration of all IV vasoactive medications | 30 days |
| Length of stay in hospital | 30 days |
| Duration of respiratory support | 30 days |
| Total amount of IV fluid administered over hospitalization | 30 days |
| Mortality (in hospital, 7-day, 30-day) | 30 days |
| Number of repeat ED visits through 30 days post-discharge | 30 days |
| Rapid response activations | 30 days |
Countries
United States
Outcome results
None listed