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Pharmacological and Mechanical Support Approaches in the Management of Acute Heart Failure in the Regional Network Model for the Management of Cardiogenic Shock

NCT06827314 · IRCCS Azienda Ospedaliero-Universitaria di Bologna
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About this study
This is a multicenter observational study with both a retrospective and a prospective cohort. Study population will include all consecutive patients diagnosed with cardiogenic shock and admitted to the cardiac intensive care unit of the participating centers. For the patients enrolled at IRCCS Azienda Ospedaliera-Universitaria di Bologna this study will involve a collaboration with UO Cardiologia. For the retrospective cohort, patients will be selected based on ICD9 discharge codes and included if they fulfill inclusion criteria after review of hospital charts. The retrospective cohort will serve as a historical comparison regarding epidemiology, treatment strategies and survival. Incidence and workload burden of CICU will be studied comparing the number of CS patients and the total number of admissions in the study period.
Eligibility criteria
Inclusion Criteria: * Adult patients (≥18 years old) admitted to a participating CICU with suspected CS of stage from C to E according to SCAI (Society of cardiovascular intervention)classification of cardiogenic shock. * Signed informed consent. Exclusion Criteria: * CS following cardiac surgery (post-cardiotomy), ● Significant polytrauma or neurological injury.
Study design
Enrollment target: 500 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-12-06
Estimated completion: 2027-11
Last updated: 2025-02-14
Primary outcomes
  • Incidence of CS over the total CICU admissions stratified by aetiologies, sex and age. (5 years)
  • Length of hospitalization, stratified by aetiologies, sex and age. (5 years)
  • CS-related in-hospital mortality stratified by aetiologies, sex and age. (5 years)
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna · other
Contacts & investigators
ContactLuciano Potena, MD · contact · scompenso.trapiantocuore@aosp.bo.it · 0512143725
InvestigatorLuciano G Potena, MD · principal_investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
All locations (1)
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruiting
Bologna, Bologna, Italy
Pharmacological and Mechanical Support Approaches in the Management of Acute Heart Failure in the Regional Network Model for the Management of Cardiogenic Shock · TrialPath