- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04028297
Focus Cardiac Ultrasound in Patients With Shock (echoshock)
Focus Cardiac Ultrasound in Patients With Undifferentiated Shock: Prospective Observational Study
Study Overview
Detailed Description
Focus cardiac ultrasound (FoCUS) has already demonstrated its ability to reduce diagnosis uncertainty in patients with undifferentiated shock. However, adequacy of initial treatment has not been investigated.
In patients with undifferentiated shock, after clinical evaluation, the physician states its hypothesis and initial treatment intention in closed list. He realizes a FoCUS, states another time the hypothesis and begins treatment according to FoCUS results. An adjudication committee with all the patient's file will state the reference hypothesis and treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Nantes, France, 44093
- Recruiting
- Nantes University Hospital
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Contact:
- Philippe Le Conte, Pr
- Phone Number: +33 02.40083.934
- Email: philippe.leconte@chu-nantes.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Undifferentiated shock defined by systolic arterial pressure < 90 mm Hg
Exclusion Criteria:
- hemorrhagic shock
- cardiac arrest
- anaphylactic shock
- documented end-of-life
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
concordance of initial treatment after FoCUS with Kappa coefficient
Time Frame: Hospitalization duration, up to one month
|
concordance between initial treatment after clinical procedure, after FoCUS in comparison with the reference stated by the adjudication committee with Kappa coefficient
|
Hospitalization duration, up to one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
duration of FoCUS
Time Frame: Hospitalization duration, up to one month
|
concordance between initial diagnosis after clinical procedure, after FoCUS in comparison with the reference stated by the adjudication committee
|
Hospitalization duration, up to one month
|
difficulty of FoCUS
Time Frame: Hospitalization duration, up to one month
|
concordance between initial diagnosis after clinical procedure, after FoCUS in comparison with the reference stated by the adjudication committee
|
Hospitalization duration, up to one month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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