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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02258984
Other study ID # 1407013246
Secondary ID
Status Enrolling by invitation
Phase N/A
First received October 3, 2014
Last updated September 25, 2015
Start date October 2014
Est. completion date December 2015

Study information

Verified date September 2015
Source Mespere Lifesciences Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 80
Est. completion date December 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Detroit Receiving Hospital Detroit Michigan

Sponsors (2)

Lead Sponsor Collaborator
Mespere Lifesciences Inc. Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30-day Readmission 30 days No
Secondary Total amount of IV fluid administered over hospitalization 30 days No
Secondary Dose, timing and duration of all IV vasoactive medications 30 days No
Secondary Length of stay in hospital 30 days No
Secondary Duration of respiratory support 30 days No
Secondary Rapid response activations 30 days No
Secondary Mortality (in hospital, 7-day, 30-day) 30 days No
Secondary Number of repeat ED visits through 30 days post-discharge 30 days No
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