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

Not Applicable

• Conditions: Acute Heart Failure; Severe Sepsis
• Interventions: Device: Mespere Venus 1000 Non-Invasive CVP System

• Registration Number: NCT02258984
• Lead Sponsor: Mespere Lifesciences Inc.

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-10-03
• Study First Posted: 2014-10-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-25
• Last Update Posted: 2015-09-28
• Primary Completion: 2015-11
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No open physician access to Venus 1000 CVP data	Mespere Venus 1000 Non-Invasive CVP System	-
Open physician access to Venus 1000 CVP data	Mespere Venus 1000 Non-Invasive CVP System	-

Primary Outcome Measures

Name	Time	Method
30-day Readmission	30 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Detroit Receiving Hospital; 🇺🇸 Detroit, Michigan, United States