NCT04028297

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

3.8 years

First QC Date

July 16, 2019

Last Update Submit

July 19, 2019

Conditions

Shock

Keywords

Shockemergencyundifferentiatedultrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • duration of FoCUS

    Hospitalization duration, up to one month

  • difficulty of FoCUS

    Hospitalization duration, up to one month

Interventions

Focus cardiac ultrasound (FoCUS)OTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with undifferentiated shock in the Emergency Department

You may qualify if:

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

You may not qualify if:

  • hemorrhagic shock
  • cardiac arrest
  • anaphylactic shock
  • documented end-of-life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

RECRUITING

MeSH Terms

Conditions

ShockEmergenciesDisorders of Sex Development

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 22, 2019

Study Start

December 1, 2015

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

July 22, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)