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

Mespere Lifesciences

Status: Unknown

Conditions: Acute Heart Failure; Severe Sepsis

Treatments: Device: Mespere Venus 1000 Non-Invasive CVP System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02258984

1407013246

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Open physician access to Venus 1000 CVP data

Other group

Treatment:

Device: Mespere Venus 1000 Non-Invasive CVP System

No open physician access to Venus 1000 CVP data

Other group

Treatment:

Device: Mespere Venus 1000 Non-Invasive CVP System