Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 3, 2014
CompletedFirst Posted
Study publicly available on registry
October 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedSeptember 28, 2015
September 1, 2015
1.1 years
October 3, 2014
September 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
30-day Readmission
30 days
Secondary Outcomes (7)
Total amount of IV fluid administered over hospitalization
30 days
Dose, timing and duration of all IV vasoactive medications
30 days
Length of stay in hospital
30 days
Duration of respiratory support
30 days
Rapid response activations
30 days
- +2 more secondary outcomes
Study Arms (2)
Open physician access to Venus 1000 CVP data
OTHERNo open physician access to Venus 1000 CVP data
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- Age 18 years old or greater
- English speaking
- Clinical diagnosis of: 1) Severe Sepsis, or 2) Acute Heart Failure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mespere Lifesciences Inc.lead
- Wayne State Universitycollaborator
Study Sites (1)
Detroit Receiving Hospital
Detroit, Michigan, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Favot, MD
Wayne State University
- PRINCIPAL INVESTIGATOR
Philip Levy, MD, FACEP
Wayne State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2014
First Posted
October 8, 2014
Study Start
October 1, 2014
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
September 28, 2015
Record last verified: 2015-09