Cardiogenic Shock AcutePROMIXNCT07354568
Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock
An observational study of Cardiogenic Shock Acute and Bypass, Cardiopulmonary, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Mixed cardiogenic-vasoplegic shock (M-CS) represents a distinct and severe phenotype of cardiogenic shock characterized by concomitant myocardial dysfunction and inappropriate systemic vasodilation. Despite its clinical relevance, the epidemiology, management, and outcomes of M-CS remain poorly defined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock Acute, Bypass, Cardiopulmonary, Septic Shock
- How many people
- 2,500 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2025to 1 Jun 2027
- 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: The study will include adult patients (>18 years old) admitted to an intensive care unit for mixed cardiogenic shock (M-CS), defined by the coexistence of low cardiac output and, when present, vasoplegia requiring vasopressor support (norepinephrine >0.15 µg/kg/min) despite adequate filling pressures. Eligible patients must meet at least SCAI stage B criteria for cardiogenic shock. Patients with major missing data, particularly on vasopressor dosing, or those who have expressed opposition to data use will be excluded. This population represents a heterogeneous, high-risk group combining features of cardiogenic and vasoplegic circulatory failure, including ischemic, post-cardiotomy, and septic cardiomyopathy etiologies. The PROMIX study aims to better characterize clinical trajectories, hemodynamic profiles, and outcomes of these patients through clustering and phenotypic analyses.
Who may be able to join
- Adult patient (>18 years old)
- Admitted to an intensive care unit for cardiogenic shock, at least SCAI stage C
- No opposition to data use
Who cannot join
- Missing key data, particularly regarding vasopressor doses and outcomes.
- Pregnant women
- Non-eligible shock etiologies, including but not limited to:
- Anaphylactic shock,
- Isolated hemorrhagic shock,
- Severe burns or major trauma,
Show all 10Show fewer
- Severe acute pancreatitis,
- Fulminant hepatic failure,
- Neurogenic shock.
- Adult under legal protection (guardianship, curatorship, or judicial protection).
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, Somme, 80000
Christophe Beyls, 0322087866, beyls.christophe59@gmail.com
Pierre Grégoire Guinot, MD, Phd
About this study
Official title: Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock: a French Multicenter Cohort
Mixed cardiogenic-vasoplegic shock (M-CS) represents a distinct and severe phenotype of cardiogenic shock characterized by concomitant myocardial dysfunction and inappropriate systemic vasodilation. Despite its clinical relevance, the epidemiology, management, and outcomes of M-CS remain poorly defined.
This retrospective, multicenter, observational registry aims to evaluate the clinical outcomes and prognostic factors associated with mixed cardiogenic-vasoplegic shock. The study will analyze clinical, biological, and invasive hemodynamic data routinely collected during patient management for M-CS.
Read more
All included patients will have been admitted for cardiogenic shock, with or without vasoplegia, defined by low cardiac output and, when present, decreased systemic vascular resistance despite adequate filling pressures requiring vasopressor support.
The primary objective is to describe mortality and organ failure rates, while secondary analyses will identify determinants of adverse outcomes and potential phenotypic subgroups.
The PROMIX registry will be conducted across three French university hospitals (CHU Amiens-Picardie, CHU Dijon-Bourgogne, and CHU Rouen-Normandie).
This study is non-interventional, involving only data obtained as part of routine critical care, and will provide the first multicenter overview of this complex and underrecognized form of cardiogenic shock.
- Conditions
- Cardiogenic Shock Acute, Bypass, Cardiopulmonary, Septic Shock, Mechanical Circulatory Support, Myocardial Infarction (MI), Cardiogenic Shock Post Myocardial Infarction
- Keywords
- VA-ECMO, Cardiogenic Shock, Mechanical Circulatory Support, Vasopressor, Mixed Cardiogenic Shock, post cardiotomy shock
- Medical subject headings
- Shock, Septic, Myocardial Infarction, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Mixed Cardiogenic-Vasoplegia Shock | Patients hospitalized in an intensive care unit (ICU) or cardiac ICU for cardiogenic shock, at least stage C according to the SCAI classification. Vasoplegia was defined by the requirement of norepinephrine > 0.20 µg/kg/min (γ/kg/min) to maintain a mean arterial pressure ≥ 65 mmHg. | |
| Patients with Cardiogenick Shock Without Vasoplegia | Patients hospitalized in an intensive care unit (ICU) or cardiac ICU for cardiogenic shock, at least stage C according to the SCAI classification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at 90 days
documented death occurring within 90 days following ICU admission
Measured: 90 days
Secondary outcomes (9)
Clinical characteristics and management trajectories
This outcome is descriptive in nature and aims to characterize the study population. Baseline variables (e.g., age, sex, cardiovascular history, comorbidities, and etiology of shock) will be reported separately using appropriate units for each variable (e.g., years, proportions, or categories), without aggregation into a single summary measure.
Measured: 90 days
Phenotyping Cardiogenic Shock by Clustering
Identification of subgroups using unsupervised classification methods (clustering) and comparison of 90-day mortality rates.
Measured: 90 days
Evolution of the SCAI Classification
Dynamic Evolution of the SCAI Classification (A to E) during the ICU stay. Each stage of classification is recording each day and during all ICU stay.
Measured: 90 days
Evolution of Arterial Pressure
To assess the dynamic evolution of systolic, diastolic, and mean blood pressure (in mmHg) from Day 0 (D0) to Day 7 (D7)
Measured: 7 days
Evolution of Norepinephrine Equivalent (NEE) Requirement
NEE (expressed in µg/kg/min) will be calculated at predefined time points: D0, D1, D3, D5, and D7, using standardized conversion factors to express all vasopressor doses as norepinephrine equivalents.
Measured: 7 days
Evolution of Vasopressor Requirement
To assess the dynamic evolution of vasopressor and inotropic support quantified using the Vasopressor-Inotropic Score (VIS).
VIS is calculated as a composite score based on standardized doses of vasopressors and inotropes, with higher scores indicating greater vasopressor and inotropic support (worse hemodynamic severity).
VIS values will be assessed at predefined time points Day 0, Day 1, Day 3, Day 5, and Day 7 after shock onset.
Measured: 7 days
Clinical outcomes
Use of renal replacement therapy and mechanical circulatory support (VA-ECMO, Impella, intra-aortic balloon pump).
Measured: 90 days
ICU length of stay
Duration of ICU length of stay (days) since the ICU admission
Measured: 90 days
Hospital lenght of stay
Duration of the Hospital lenght of stay (days) since the hospital admission and home discharge.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start20 Oct 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic Shock AcuteStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyls, Centre Hospitalier Universitaire, Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354568
- Sponsor's protocol ID
- PI2025_843_0187
- Other IDs
- N° HDH : 27130053
- Acronym
- PROMIX
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 21 Jan 2026
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock: a French Multicenter Cohort
- ClinicalTrials.gov ID
- NCT07354568
- Acronym / sponsor ID
- PROMIX / PI2025_843_0187
- Conditions
- Cardiogenic Shock Acute, Bypass, Cardiopulmonary, Septic Shock, Mechanical Circulatory Support, Myocardial Infarction (MI), Cardiogenic Shock Post Myocardial Infarction
- Keywords
- VA-ECMO, Cardiogenic Shock, Mechanical Circulatory Support, Vasopressor, Mixed Cardiogenic Shock, post cardiotomy shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon, University Hospital, Rouen
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 21 Jan 2026 (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.
Mixed cardiogenic-vasoplegic shock (M-CS) represents a distinct and severe phenotype of cardiogenic shock characterized by concomitant myocardial dysfunction and inappropriate systemic vasodilation. Despite its clinical relevance, the epidemiology, management, and outcomes of M-CS remain poorly defined.
This retrospective, multicenter, observational registry aims to evaluate the clinical outcomes and prognostic factors associated with mixed cardiogenic-vasoplegic shock. The study will analyze clinical, biological, and invasive hemodynamic data routinely collected during patient management for M-CS.
All included patients will have been admitted for cardiogenic shock, with or without vasoplegia, defined by low cardiac output and, when present, decreased systemic vascular resistance despite adequate filling pressures requiring vasopressor support.
The primary objective is to describe mortality and organ failure rates, while secondary analyses will identify determinants of adverse outcomes and potential phenotypic subgroups.
The PROMIX registry will be conducted across three French university hospitals (CHU Amiens-Picardie, CHU Dijon-Bourgogne, and CHU Rouen-Normandie).
This study is non-interventional, involving only data obtained as part of routine critical care, and will provide the first multicenter overview of this complex and underrecognized form of cardiogenic shock.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Mixed Cardiogenic-Vasoplegia Shock | – | –Patients hospitalized in an intensive care unit (ICU) or cardiac ICU for cardiogenic shock, at least stage C according to the SCAI classification. Vasoplegia was defined by the requirement of norepinephrine > 0.20 µg/kg/min (γ/kg/min) to maintain a mean arterial pressure ≥ 65 mmHg. |
| Patients with Cardiogenick Shock Without Vasoplegia | – | –Patients hospitalized in an intensive care unit (ICU) or cardiac ICU for cardiogenic shock, at least stage C according to the SCAI classification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult patients (>18 years old) admitted to an intensive care unit for mixed cardiogenic shock (M-CS), defined by the coexistence of low cardiac output and, when present, vasoplegia requiring vasopressor support (norepinephrine >0.15 µg/kg/min) despite adequate filling pressures. Eligible patients must meet at least SCAI stage B criteria for cardiogenic shock. Patients with major missing data, particularly on vasopressor dosing, or those who have expressed opposition to data use will be excluded. This population represents a heterogeneous, high-risk group combining features of cardiogenic and vasoplegic circulatory failure, including ischemic, post-cardiotomy, and septic cardiomyopathy etiologies. The PROMIX study aims to better characterize clinical trajectories, hemodynamic profiles, and outcomes of these patients through clustering and phenotypic analyses.
Key inclusion criteria (3 listed)
- Adult patient (>18 years old)
- Admitted to an intensive care unit for cardiogenic shock, at least SCAI stage C
- No opposition to data use
Key exclusion criteria (10 listed)
- Missing key data, particularly regarding vasopressor doses and outcomes.
- Pregnant women
- Non-eligible shock etiologies, including but not limited to:
- Anaphylactic shock,
- Isolated 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
All-cause mortality at 90 days
Time frame: 90 days
documented death occurring within 90 days following ICU admission
9 secondary outcomes
Clinical characteristics and management trajectories
Time frame: 90 days
Phenotyping Cardiogenic Shock by Clustering
Time frame: 90 days
Evolution of the SCAI Classification
Time frame: 90 days
Evolution of Arterial Pressure
Time frame: 7 days
Evolution of Norepinephrine Equivalent (NEE) Requirement
Time frame: 7 days
Evolution of Vasopressor Requirement
Time frame: 7 days
Clinical outcomes
Time frame: 90 days
ICU length of stay
Time frame: 90 days
Hospital lenght of stay
Time frame: 90 days
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 21 Jan 2026.
- 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.
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 Acute and Bypass, Cardiopulmonary, 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 3 inclusion and 10 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 21 Jan 2026. 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, PhD (+ 33 322087866, 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?
All-cause mortality at 90 days (time frame: 90 days). 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 21 Jan 2026.