Cardiogenic ShockHEMOCARDNCT05752383
The Clinical and Hemodynamic Course of Cardiogenic Shocks Hospitalized in Critical Care
An observational study of Cardiogenic Shock, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Cardiogenic shock is a frequent reason for hospitalization in critical care units, with high mortality (50%). Several French registries have been created to improve knowledge of the prognostic factors of cardiogenic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2023to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 hospitalized in ICU for cardiogenic shock * Patient with cardiogenic shock as defined by the FRENSCHOCK2 study criteria
Who may be able to join
- Patients hospitalized in ICU for cardiogenic shock
- Patient with cardiogenic shock as defined by the FRENSCHOCK2 study criteria
Who cannot join
- Patient with cardiogenic shock in the context of septic shock and hemorrhagic shock
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens
Christophe Beyls, MD, 0322087866, Beyls.Christophe@chu-amiens.fr
About this study
Cardiogenic shock is a frequent reason for hospitalization in critical care units, with high mortality (50%). Several French registries have been created to improve knowledge of the prognostic factors of cardiogenic shock. In recent years, temporary mechanical circulatory support has become more important in cardiogenic shock. The monitoring of catecholamines is also performed with a global score: the vaso-inotropic score. The purpose of our study is to consider using these new data and techniques to create a cohort of cardiogenic shock within our critical care unit.
This observational study is based on clinical, biological, and hemodynamic data recorded during the ICU stay of patients for cardiogenic shock.
The primary endpoint is the relationship between the hemodynamic evolution of cardiogenic shock and in-hospital mortality.
- Conditions
- Cardiogenic Shock
- Keywords
- Cardiogenic Shock, vaso-inotropic score
- Medical subject headings
- Shock, Cardiogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of in-hospital mortality after cardiogenic shock
Measured: 5 years
Vaso-inotropic score after cardiogenic shock
vasoactive-inotropic score (VIS) Maximal VIS (VISmax) is calculated using the highest doses of vasoactive and inotropic medications administered.
VISmax categories: 0-5, >5-15, >15-30, >30-45, and >45 points.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start24 Jan 2023
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752383
- Sponsor's protocol ID
- PI2022_843_0132
- Acronym
- HEMOCARD
- Status last verified
- Jan 2023
- First submitted
- 24 Jan 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Hemodynamic Course of Cardiogenic Shocks Hospitalized in Critical Care
- ClinicalTrials.gov ID
- NCT05752383
- Acronym / sponsor ID
- HEMOCARD / PI2022_843_0132
- Conditions
- Cardiogenic Shock
- Keywords
- Cardiogenic Shock, vaso-inotropic score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 2 Mar 2023 (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.
Cardiogenic shock is a frequent reason for hospitalization in critical care units, with high mortality (50%). Several French registries have been created to improve knowledge of the prognostic factors of cardiogenic shock. In recent years, temporary mechanical circulatory support has become more important in cardiogenic shock. The monitoring of catecholamines is also performed with a global score: the vaso-inotropic score. The purpose of our study is to consider using these new data and techniques to create a cohort of cardiogenic shock within our critical care unit.
This observational study is based on clinical, biological, and hemodynamic data recorded during the ICU stay of patients for cardiogenic shock.
The primary endpoint is the relationship between the hemodynamic evolution of cardiogenic shock and in-hospital mortality.
Study design
- Observational model
- Case only
- 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 hospitalized in ICU for cardiogenic shock * Patient with cardiogenic shock as defined by the FRENSCHOCK2 study criteria
Key inclusion criteria (2 listed)
- Patients hospitalized in ICU for cardiogenic shock
- Patient with cardiogenic shock as defined by the FRENSCHOCK2 study criteria
Key exclusion criteria (1 listed)
- Patient with cardiogenic shock in the context of septic shock and hemorrhagic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of in-hospital mortality after cardiogenic shock
Time frame: 5 years
Vaso-inotropic score after cardiogenic shock
Time frame: 5 years
vasoactive-inotropic score (VIS) Maximal VIS (VISmax) is calculated using the highest doses of vasoactive and inotropic medications administered. VISmax categories: 0-5, >5-15, >15-30, >30-45, and >45 points.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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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.
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 Cardiogenic Shock, run by Centre Hospitalier Universitaire, Amiens 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 Mar 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Beyls, MD (03 22 08 78 66, beyls.christophe@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of in-hospital mortality after cardiogenic shock (time frame: 5 years). The study lists 2 primary outcomes in all. 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 2 Mar 2023.