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

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.

Study Overview

• Status: Unknown
• Conditions: Severe Sepsis; Acute Heart Failure
• Intervention / Treatment: Device: Mespere Venus 1000 Non-Invasive CVP System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States
      • Detroit Receiving Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open physician access to Venus 1000 CVP data	Device: Mespere 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.
Other: No open physician access to Venus 1000 CVP data	Device: Mespere 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30-day Readmission	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of stay in hospital	30 days
Total amount of IV fluid administered over hospitalization	30 days
Dose, timing and duration of all IV vasoactive medications	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

Collaborators and Investigators

• Sponsor: Mespere Lifesciences Inc.
• Collaborators: Wayne State University
• Investigators: Principal Investigator: Mark Favot, MD, Wayne State University; Principal Investigator: Philip Levy, MD, FACEP, Wayne State University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: October 3, 2014
• First Submitted That Met QC Criteria: October 3, 2014
• First Posted (Estimate): October 8, 2014

Study Record Updates

• Last Update Posted (Estimate): September 28, 2015
• Last Update Submitted That Met QC Criteria: September 25, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Heart Failure; Sepsis; Toxemia
• Other Study ID Numbers: 1407013246