Severe SepsisNCT02258984
Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial
A study testing Mespere Venus 1000 Non-Invasive CVP System in people with Severe Sepsis and Acute Heart Failure, run by Mespere Lifesciences Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Acute Heart Failure
- What is being tested?
- Mespere Venus 1000 Non-Invasive CVP System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years old or greater
- English speaking
- Clinical diagnosis of: 1) Severe Sepsis, or 2) Acute Heart Failure
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Severe Sepsis, Acute Heart Failure
- Being tested
- Mespere Venus 1000 Non-Invasive CVP System
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mespere Venus 1000 Non-Invasive CVP SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Open physician access to Venus 1000 CVP data | Other | Not described Receives: Device: Mespere Venus 1000 Non-Invasive CVP System |
| No open physician access to Venus 1000 CVP data | Other | Not described Receives: Device: Mespere Venus 1000 Non-Invasive CVP System |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day Readmission
Measured: 30 days
Secondary outcomes (7)
Total amount of IV fluid administered over hospitalization
Measured: 30 days
Dose, timing and duration of all IV vasoactive medications
Measured: 30 days
Length of stay in hospital
Measured: 30 days
Duration of respiratory support
Measured: 30 days
Rapid response activations
Measured: 30 days
Mortality (in hospital, 7-day, 30-day)
Measured: 30 days
Number of repeat ED visits through 30 days post-discharge
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mespere Lifesciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wayne State University
- Responsible party
- Sponsor
- Investigators
- Mark Favot, MD, Principal investigator, Wayne State UniversityPhilip Levy, MD, FACEP, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258984
- Sponsor's protocol ID
- 1407013246
- Status last verified
- Sep 2015
- First submitted
- 3 Oct 2014
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial
- ClinicalTrials.gov ID
- NCT02258984
- Acronym / sponsor ID
- 1407013246
- Conditions
- Severe Sepsis, Acute Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mespere Lifesciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Wayne State University
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open physician access to Venus 1000 CVP data | Other | Device: Mespere Venus 1000 Non-Invasive CVP System |
| No open physician access to Venus 1000 CVP data | Other | Device: Mespere Venus 1000 Non-Invasive CVP System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years old or greater
- English speaking
- Clinical diagnosis of: 1) Severe Sepsis, or 2) Acute Heart Failure
Key exclusion criteria (7 listed)
- Traumatic injuries
- Active bleeding
- Pregnancy
- Prisoners
- Central venous catheter placement in the internal jugular or subclavian veins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mespere Venus 1000 Non-Invasive CVP SystemThe 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. | Device | No open physician access to Venus 1000 CVP data, Open physician access to Venus 1000 CVP data |
Primary outcome
30-day Readmission
Time frame: 30 days
7 secondary outcomes
Total amount of IV fluid administered over hospitalization
Time frame: 30 days
Dose, timing and duration of all IV vasoactive medications
Time frame: 30 days
Length of stay in hospital
Time frame: 30 days
Duration of respiratory support
Time frame: 30 days
Rapid response activations
Time frame: 30 days
Mortality (in hospital, 7-day, 30-day)
Time frame: 30 days
Number of repeat ED visits through 30 days post-discharge
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Favot, MD principal investigator
Wayne State University
Philip Levy, MD, FACEP principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mespere Venus 1000 Non-Invasive CVP System in people with Severe Sepsis and Acute Heart Failure, run by Mespere Lifesciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day Readmission (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.