Focus Cardiac Ultrasound in Patients With Shock

Shock Clinical Trial

— echoshock  

Official title:

Focus Cardiac Ultrasound in Patients With Undifferentiated Shock: Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028297
• Other study ID #: 2015-035
• Status: Recruiting
• Start date: December 1, 2015
• Est. completion date: December 1, 2019

Study information

• Verified date: July 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• hemorrhagic shock

• cardiac arrest

• anaphylactic shock

• documented end-of-life

Related Conditions & MeSH terms

• Shock

Intervention

Other:
• Focus cardiac ultrasound (FoCUS)

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concordance of initial treatment after FoCUS with Kappa coefficient	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	duration of FoCUS	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
Secondary	difficulty of FoCUS	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