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ED Decision Making Among Hypotensive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02221908
Recruitment Status : Unknown
Verified September 2015 by Mespere Lifesciences Inc..
Recruitment status was:  Enrolling by invitation
First Posted : August 21, 2014
Last Update Posted : September 28, 2015
Information provided by (Responsible Party):
Mespere Lifesciences Inc.

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

Condition or disease Intervention/treatment
Hypotension Device: Mespere Venus 1000 CVP System

Detailed Description:
If physicians can make appropriate decisions about the need for fluid resuscitation without CVP measurement, then this skill is worth being passed to physicians in training. Previously it was not possible gather enough information about the response of patients' because of the risk of using indwelling CVP sensors. But now because there is a low risk tool (Venus 1000 System), this study is now practical and safe.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ED Decision Making Among Hypotensive Patients
Study Start Date : August 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients brought to Hahnemann Hospital ED Device: Mespere Venus 1000 CVP System

Primary Outcome Measures :
  1. The correspondence of resuscitation decision and CVP value [ Time Frame: At patient admission to ED ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients brough to Hahnemann Hospital ED

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  • Additional exclusion criteria include the presence of an internal jugular or a subclavian central venous line or both external jugular veins being cannulated (attempted or successful) with peripheral IVs.
  • Pregnant females will be excluded.
  • Subjects under the age of 18 years will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02221908

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United States, Pennsylvania
Hahnemann Hospital
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Mespere Lifesciences Inc.
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Principal Investigator: Neal Handly, MD Drexel University
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Responsible Party: Mespere Lifesciences Inc. Identifier: NCT02221908    
Other Study ID Numbers: IRB1401002513
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015
Keywords provided by Mespere Lifesciences Inc.:
Systolic Blood pressure < 100 mm Hg
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases