Acute Decompensated Heart Failure, Cardiogenic Shock, Fulminant Myocarditis, Myocardial Infarction (MI), Perioperative Cardiogenic Shock, Post-cardiotomy, Severe Valvular Disease
Conditions
Keywords
cardiogenic shock, Myocardial infarction (MI), Fulminant myocarditis, Acute decompensated heart failure, Severe valvular disease, Post-cardiotomy or perioperative cardiogenic shock, wide range of cardiogenic shock etiologies
Brief summary
This regulation defines the purpose, the operational processes, and the organization of the registry BEAT-SHOCK (Basel Evaluation of Acute Therapy in cardiogenic SHOCK). It describes the requirements for collecting, storing, processing, managing and sharing health-related registry data.
Interventions
OTHERno internvention
This is a health data registry.
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients admitted with cardiogenic shock to the University hospital Basel (diagnosis at the time of admission) or development of cardiogenic shock during the hospital stay * Age ≥18 years * Provision of written ICF * Clinical diagnosis of cardiogenic shock. * impaired organ perfusion due to primary cardiac dysfunction, * persistent systolic blood pressure (SBP) \<90 mmHg for ≥30 minutes, or the need for vasopressors, inotropes, or mechanical circulatory support (MCS) to maintain adequate perfusion and * evidence of systemic hypoperfusion with arterial lactate ≥2 mmol/L or venous lactate ≥3 mmol/l and ≥1 of the following: * Cold or clammy extremities * Altered mental status * Reduced urine output * Signs of volume overload or congestion (on clinical exam, imaging, or invasive monitoring) * Patients with normotensive cardiogenic shock (SBP ≥90 mmHg without vasopressors or MCS) may also be included if clear signs of hypoperfusion (arterial lactate ≥2 mmol/L or venous lactate ≥3 mmol/l) and cardiac dysfunction are present and alternative causes are excluded
Exclusion criteria
* Age \<18 years * Refusal to provide informed consent by the patient or their legally authorized representative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-Hospital all-cause mortality occurring before discharge from the participating study centre | 10 years | In-hospital all-cause mortality is defined as death occurring before discharge from the participating study centre. Deaths occurring after transfer to an external hospital are not counted as in-hospital deaths, but are captured through follow-up for 30-day and 90-day mortality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day and 90-day all-cause Mortality | 30, 90 days | 30-day and 90-day all-cause mortality occuring after discharge from the participating study centre. |
| Need for organ support at any time during hospitalization | 30, 60, 360 days | The need for organ support at any time during hospitalization (including renal replacement therapy, mechanical circulation support irrespective of type, and vasoactive or inotropic therapy) |
| Acute kidney injury (AKI) within 36 hours after index diagnosis of cardiogenic shock/index presentation | Within 36 hours after index diagnosis of cardiogenic shock/ index presentation. | Occurence of AKI (defined as an increase in serum creatinine of at least 26 µmol/L (0.3 mg/dL) |
Countries
Switzerland
Contacts
CONTACTJasper Boeddinghaus, PD Dr. med.
CONTACTGregor Leibundgut, Prof. Dr.
Outcome results
None listed