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

Primary Purpose

Severe Sepsis, Acute Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mespere Venus 1000 Non-Invasive CVP System
Sponsored by
Mespere Lifesciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Detroit Receiving Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Open physician access to Venus 1000 CVP data

No open physician access to Venus 1000 CVP data

Arm Description

Outcomes

Primary Outcome Measures

30-day Readmission

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2014
Last Updated
September 25, 2015
Sponsor
Mespere Lifesciences Inc.
Collaborators
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT02258984
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mespere Lifesciences Inc.
Collaborators
Wayne State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Acute Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open physician access to Venus 1000 CVP data
Arm Type
Other
Arm Title
No open physician access to Venus 1000 CVP data
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Mespere Venus 1000 Non-Invasive CVP System
Intervention Description
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.
Primary Outcome Measure Information:
Title
30-day Readmission
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Total amount of IV fluid administered over hospitalization
Time Frame
30 days
Title
Dose, timing and duration of all IV vasoactive medications
Time Frame
30 days
Title
Length of stay in hospital
Time Frame
30 days
Title
Duration of respiratory support
Time Frame
30 days
Title
Rapid response activations
Time Frame
30 days
Title
Mortality (in hospital, 7-day, 30-day)
Time Frame
30 days
Title
Number of repeat ED visits through 30 days post-discharge
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Favot, MD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philip Levy, MD, FACEP
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
Country
United States

12. IPD Sharing Statement

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

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