Clinical trial NCT02258984: Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial
Official title: Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Sepsis
Acute Heart Failure
Lead sponsor: Mespere Lifesciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: Wayne State University
First posted: 2014-10-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day Readmission
timeFrame: 30 days
Secondary outcomes:
measure: Total amount of IV fluid administered over hospitalization
timeFrame: 30 days
measure: Dose, timing and duration of all IV vasoactive medications
timeFrame: 30 days
measure: Length of stay in hospital
timeFrame: 30 days
measure: Duration of respiratory support
timeFrame: 30 days
measure: Rapid response activations
timeFrame: 30 days
measure: Mortality (in hospital, 7-day, 30-day)
timeFrame: 30 days
measure: Number of repeat ED visits through 30 days post-discharge
timeFrame: 30 days
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
Study officials:
affiliation: Wayne State University
name: Mark Favot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Philip Levy, MD, FACEP
role: PRINCIPAL_INVESTIGATOR
References: