NCT02221908

Brief Summary

The goal of this study is to assess decision making skills of emergency physicians when dealing with hypotensive patients. The hypothesis is that decisions made based on physical exam and vital signs regarding fluid resuscitation by emergency physicians are not statistically equivalent to those that would be made based on the use of a non-invasive CVP measurement

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

1.6 years

First QC Date

August 18, 2014

Last Update Submit

September 25, 2015

Conditions

Hypotension

Keywords

Systolic Blood pressure < 100 mm Hg

Outcome Measures

Primary Outcomes (1)

  • The correspondence of resuscitation decision and CVP value

    The non-invasive CVP will be measured at the time of initial ordering decision by the ED physician. Afterwards, its relationship to the decision about whether to start intravenous fluid resuscitation will be analyzed.

    At patient admission to ED

Study Arms (1)

Patients brought to Hahnemann Hospital ED

Device: Mespere Venus 1000 CVP System

Interventions

Mespere Venus 1000 CVP SystemDEVICE
Patients brought to Hahnemann Hospital ED

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients brough to Hahnemann Hospital ED

You may qualify if:

  • All patients \>=18 years of age who enter the Emergency Department at Hahnemann Hospital with Systolic Blood pressure \< 100 mm Hg

You may not qualify if:

  • Those patients who are suffering from traumatic injury requiring Level I or Level II trauma evaluations. Example conditions include penetrating injuries to head, torso and proximal extremities.
  • Pregnant females will be excluded.
  • Subjects under the age of 18 years will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hahnemann Hospital

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Neal Handly, MD

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 21, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

September 28, 2015

Record last verified: 2015-09

Locations

US(1)