Focus Cardiac Ultrasound in Patients With Shock

• Conditions: Shock

• Registration Number: NCT04028297
• Lead Sponsor: Nantes University Hospital

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 Timeline

• Study Start: 2015-12-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-19
• Last Update Submitted: 2019-07-19
• Study First Posted: 2019-07-22
• Last Update Posted: 2019-07-22
• Primary Completion: 2019-09-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
concordance of initial treatment after FoCUS with Kappa coefficient	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

Name	Time	Method
duration of FoCUS	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	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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France