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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

CS following cardiac surgery (post-cardiotomy), ● Significant polytrauma or neurological injury.

Trial population

For the prospective cohort, study population consists of all consecutive patients diagnosed with CS and admitted to participating CICUs in the Emilia Romagna region. For the prospective cohort patients will be enrolled after study approval and until 31 December 2027. Patients will be enrolled upon admission or at the development of CS if already admitted. Retrospective data will be collected for five years, starting from January 1st 2018 until the starting date of the study.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Incidence of CS over the total CICU admissions stratified by aetiologies, sex and age.

Incidence

Time frame
5 years
2

Length of hospitalization, stratified by aetiologies, sex and age.

Days

Time frame
5 years
3

CS-related in-hospital mortality stratified by aetiologies, sex and age.

Incidence

Time frame
5 years
4

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.

Demography description

Time frame
5 years

Secondary outcomes

1

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.

Rate of successful bridge to heart replacement therapy

Time frame
5 years
2

Comparison of survival between patients who underwent HRT as a consequence of CS to elective patients in the study period

Comparison of survival

Time frame
5 years
3

Description of in-hospital complications such as rate of renal replacement therapy, number of nosocomial infections with therapy and consequent associated mortality.

Description of in-hospital complications

Time frame
5 years
4

Description of MCS-related complications, including bleeding requiring transfusions, vascular complications including bleeding requiring intervention and limb ischemia.

Description of MCS-related complications

Time frame
5 years

Other outcomes

Sponsors and contacts

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