Pharmacological and Mechanical Support Approaches in the Management of Acute Heart Failure in the Regional Network Model for the Management of Cardiogenic Shock
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiogenic Shock, Acute Coronary Event. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this observational study is to understand and describe the epidemiology of cardiogenic shock in Emilia Romagna with a specific focus on outcome stratified by aetiologies, sex and age. The main outcomes are: * Incidence of cardiogenic shock (CS) over the total CICU admissions, CS-related in-hospital mortality and length of hospitalization, stratified by aetiologies, sex and age * Epidemiology of patients admitted with CS, regarding age, gender, etiology and modality of presentation (acute or acute on chronic), echocardiographic and haemodynamic data, treatment strategy with inotropes and/or short-term MCS, cardiac arrest. This is an observational study without intervention. Patients will be treated according to current clinical practice, according to physician judgment and data sheets of each drug used according to clinical practice.
Detailed description
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.
Primary outcome measures
- Incidence of CS over the total CICU admissions stratified by aetiologies, sex and age. [Time frame: 5 years]
- Length of hospitalization, stratified by aetiologies, sex and age. [Time frame: 5 years]
- CS-related in-hospital mortality stratified by aetiologies, sex and age. [Time frame: 5 years]
- Epidemiology of patients admitted with CS, regarding age, gender, etiology and modality of presentation (acute or acute on chronic), echocardiographic and haemodynamic data, treatment strategy with inotropes and/or short-term MCS, cardiac arrest. [Time frame: 5 years]
- Recovery from cardiogenic shock, defined as improvement to at least SCAI stage B or discharge from CICU to a step-down ward [Time frame: 5 years]
- In-hospital survival according to age, etiology, presentation (acute or acute on chronic) and modality of treatment (inotropes or MCS). [Time frame: 5 years]
- Rate and reason of unplanned re-hospitalizations within one month after primary discharge [Time frame: 5 years]
- Workload burden will be estimated as the percentage of CS admission and the mean duration of CICU stay as compared to other admissions during study period [Time frame: 5 years]
- Rate of adherence to several items and differences between older era (retrospective data) and prospective cohort [Time frame: 5 years]
Secondary outcome measures (4)
- Rate of successful bridge to heart replacement therapy (heart transplant or LVAD implant) in patients potentially eligible (i.e. age < 71 years old) and transferred to IRCCS Policlinico S.Orsola hub center. [Time frame: 5 years]
- Comparison of survival between patients who underwent HRT as a consequence of CS to elective patients in the study period [Time frame: 5 years]
- Description of in-hospital complications such as rate of renal replacement therapy, number of nosocomial infections with therapy and consequent associated mortality. [Time frame: 5 years]
- Description of MCS-related complications, including bleeding requiring transfusions, vascular complications including bleeding requiring intervention and limb ischemia. [Time frame: 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06827314 · Shock-ER