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NCT Number: NCT07354568

Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock

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.

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Key information

Conditions

Cardiogenic Shock Acute Bypass, Cardiopulmonary Cardiogenic Shock Post Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Infections Inflammation Ischemia Mechanical Circulatory Support Myocardial Infarction Myocardial Infarction (MI) Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Cardiogenic Shock, Septic Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens Picardie

Amiens, Somme, 80000, France

Location status: Recruiting

Location contact

Christophe Beyls

CONTACT

[email protected]

0322087866

Emmanuel Besnier, MD, PhD

SUB_INVESTIGATOR

Pierre Grégoire Guinot, MD, Phd

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient (>18 years old)
  • Admitted to an intensive care unit for cardiogenic shock, at least SCAI stage C
  • No opposition to data use

Exclusion criteria

  • 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,
  • Severe acute pancreatitis,
  • Fulminant hepatic failure,
  • Neurogenic shock.
  • Adult under legal protection (guardianship, curatorship, or judicial protection).

Treatment and study plan

Primary outcomes

  1. All-cause mortality at 90 days

    Time frame: 90 days

    documented death occurring within 90 days following ICU admission

Secondary outcomes

  1. Clinical characteristics and management trajectories

    Time frame: 90 days

    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.

  2. Phenotyping Cardiogenic Shock by Clustering

    Time frame: 90 days

    Identification of subgroups using unsupervised classification methods (clustering) and comparison of 90-day mortality rates.

  3. Evolution of the SCAI Classification

    Time frame: 90 days

    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.

  4. Evolution of Arterial Pressure

    Time frame: 7 days

    To assess the dynamic evolution of systolic, diastolic, and mean blood pressure (in mmHg) from Day 0 (D0) to Day 7 (D7)

  5. Evolution of Norepinephrine Equivalent (NEE) Requirement

    Time frame: 7 days

    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.

  6. Evolution of Vasopressor Requirement

    Time frame: 7 days

    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.

  7. Clinical outcomes

    Time frame: 90 days

    Use of renal replacement therapy and mechanical circulatory support (VA-ECMO, Impella, intra-aortic balloon pump).

  8. ICU length of stay

    Time frame: 90 days

    Duration of ICU length of stay (days) since the ICU admission

  9. Hospital lenght of stay

    Time frame: 90 days

    Duration of the Hospital lenght of stay (days) since the hospital admission and home discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Beyls, MD, PhD

CONTACT

[email protected]

+ 33 322087866

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Centre Hospitalier Universitaire Dijon
  • University Hospital, Rouen

Registry information

Official study title

Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock: a French Multicenter Cohort

Acronym: PROMIX

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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