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出境医 / 临床实验 / Focus Cardiac Ultrasound in Patients With Shock (echoshock)

Focus Cardiac Ultrasound in Patients With Shock (echoshock)

Study Description
Brief Summary:
The aim of this study is to analyze in patients with undifferentiated shock, the concordance of initial treatment before and after Focus cardiac ultrasound (FoCUS) in comparison with the reference one established by an adjudication committee

Condition or disease Intervention/treatment
Shock Other: Focus cardiac ultrasound (FoCUS)

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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Focus Cardiac Ultrasound in Patients With Undifferentiated Shock: Prospective Observational Study
Actual Study Start Date : December 1, 2015
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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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:   Probability Sample
Study Population
Patients with undifferentiated shock in the Emergency Department
Criteria

Inclusion Criteria:

  • Undifferentiated shock defined by systolic arterial pressure < 90 mm Hg

Exclusion Criteria:

  • hemorrhagic shock
  • cardiac arrest
  • anaphylactic shock
  • documented end-of-life
Contacts and Locations

Locations
Layout table for location information
France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Philippe Le Conte, Pr    02.40083.934 ext +33    philippe.leconte@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Tracking Information
First Submitted Date July 16, 2019
First Posted Date July 22, 2019
Last Update Posted Date July 22, 2019
Actual Study Start Date December 1, 2015
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 19, 2019) 		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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 19, 2019)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Focus Cardiac Ultrasound in Patients With Shock
Official Title Focus Cardiac Ultrasound in Patients With Undifferentiated Shock: Prospective Observational Study
Brief Summary The aim of this study is to analyze in patients with undifferentiated shock, the concordance of initial treatment before and after Focus cardiac ultrasound (FoCUS) in comparison with the reference one established by an adjudication committee
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with undifferentiated shock in the Emergency Department
Condition Shock
Intervention Other: Focus cardiac ultrasound (FoCUS)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 19, 2019) 		84
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2019
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Undifferentiated shock defined by systolic arterial pressure < 90 mm Hg

Exclusion Criteria:

  • hemorrhagic shock
  • cardiac arrest
  • anaphylactic shock
  • documented end-of-life
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04028297
Other Study ID Numbers 2015-035
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Nantes University Hospital
Verification Date July 2019

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