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

Severe Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02258984
• Other study ID #: 1407013246
• 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

• Acute Heart Failure
• Heart Failure
• Sepsis
• Severe Sepsis

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