ShockechoshockNCT04028297
Focus Cardiac Ultrasound in Patients With Shock
An observational study of Shock, run by Nantes University Hospital at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- Focus cardiac ultrasound (FoCUS)
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2015to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with undifferentiated shock in the Emergency Department
Who may be able to join
- Undifferentiated shock defined by systolic arterial pressure < 90 mm Hg
Who cannot join
- hemorrhagic shock
- cardiac arrest
- anaphylactic shock
- documented end-of-life
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, 44093
Philippe Le Conte, Pr, 02.40083.934 ext. +33, philippe.leconte@chu-nantes.fr
About this study
Official title: Focus Cardiac Ultrasound in Patients With Undifferentiated Shock: Prospective Observational Study
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
Read the 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
- Conditions
- Shock
- Being tested
- Focus cardiac ultrasound (FoCUS)
- Keywords
- Shock, emergency, undifferentiated, ultrasound
- Medical subject headings
- Shock, Emergencies, Disorders of Sex Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus cardiac ultrasound (FoCUS)Other
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Hospitalization duration, up to one month
Secondary outcomes (2)
duration of FoCUS
concordance between initial diagnosis after clinical procedure, after FoCUS in comparison with the reference stated by the adjudication committee
Measured: Hospitalization duration, up to one month
difficulty of FoCUS
concordance between initial diagnosis after clinical procedure, after FoCUS in comparison with the reference stated by the adjudication committee
Measured: Hospitalization duration, up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start1 Dec 2015
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028297
- Sponsor's protocol ID
- 2015-035
- Acronym
- echoshock
- Status last verified
- Jul 2019
- First submitted
- 16 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focus Cardiac Ultrasound in Patients With Undifferentiated Shock: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04028297
- Acronym / sponsor ID
- echoshock / 2015-035
- Conditions
- Shock
- Keywords
- Shock, emergency, undifferentiated, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with undifferentiated shock in the Emergency Department
Key inclusion criteria (1 listed)
- Undifferentiated shock defined by systolic arterial pressure < 90 mm Hg
Key exclusion criteria (4 listed)
- hemorrhagic shock
- cardiac arrest
- anaphylactic shock
- documented end-of-life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus cardiac ultrasound (FoCUS) | Other | – |
Primary outcome
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
2 secondary outcomes
duration of FoCUS
Time frame: Hospitalization duration, up to one month
difficulty of FoCUS
Time frame: Hospitalization duration, up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concordance of initial treatment after FoCUS with Kappa coefficient (time frame: Hospitalization duration, up to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.