Acute Coronary Event, Cardiogenic Shock
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adherence to several items and differences between older era (retrospective data) and prospective cohort | 5 years | Blood counts, ECG, oxygen saturation and respiratory monitoring. |
| Recovery from cardiogenic shock, defined as improvement to at least SCAI stage B or discharge from CICU to a step-down ward | 5 years | Recovery from cardiogenic shock |
| In-hospital survival according to age, etiology, presentation (acute or acute on chronic) and modality of treatment (inotropes or MCS). | 5 years | In-hospital survival |
| Rate and reason of unplanned re-hospitalizations within one month after primary discharge | 5 years | Rate and reason of unplanned re-hospitalizations |
| 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 | 5 years | Workload burden |
| Incidence of CS over the total CICU admissions stratified by aetiologies, sex and age. | 5 years | Incidence |
| Length of hospitalization, stratified by aetiologies, sex and age. | 5 years | Days |
| CS-related in-hospital mortality stratified by aetiologies, sex and age. | 5 years | Incidence |
| 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. | 5 years | Demography description |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of survival between patients who underwent HRT as a consequence of CS to elective patients in the study period | 5 years | Comparison of survival |
| Description of in-hospital complications such as rate of renal replacement therapy, number of nosocomial infections with therapy and consequent associated mortality. | 5 years | Description of in-hospital complications |
| Description of MCS-related complications, including bleeding requiring transfusions, vascular complications including bleeding requiring intervention and limb ischemia. | 5 years | Description of MCS-related complications |
| 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. | 5 years | Rate of successful bridge to heart replacement therapy |
Countries
Italy
Contacts
Primary ContactLuciano Potena, MD
Outcome results
None listed