BEAT-SHOCK Registry

University Hospital, Basel, Switzerland8,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

8,000

Conditions

Cardiogenic Shock Myocardial Infarction (MI)Fulminant Myocarditis Acute Decompensated Heart Failure Severe Valvular Disease Post-cardiotomy Perioperative Cardiogenic Shock

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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

Outcomes

Primary Outcomes

In-Hospital all-cause mortality occurring before discharge from the participating study centre

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.

Time frame: 10 years

Secondary Outcomes

30-day and 90-day all-cause Mortality

30-day and 90-day all-cause mortality occuring after discharge from the participating study centre.

Time frame: 30, 90 days

Need for organ support at any time during hospitalization

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)

Time frame: 30, 60, 360 days

Acute kidney injury (AKI) 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)

Time frame: Within 36 hours after index diagnosis of cardiogenic shock/ index presentation.

Central Contacts

Jasper Boeddinghaus, PD Dr. med.

CONTACT

0041613287897 jasper.boeddinghaus@usb.ch

Gregor Leibundgut, Prof. Dr.