Lower Silesia Cardiogenic Shock Initiative

Study Overview
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Brief Summary
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LSCSI is a Hub&Spoke project with the main aim to improve the outcome of patients with cardiogenic shock in Lower Silesia region, Poland. It consists of one hub which is Wroclaw University Hospital and eleven spokes which are eleven cardiology departments situated in Lower Silesian Voivodeship. The consortium have unified protocol defining which cardiogenic shock patient and when should be transferred to the hub for enhanced treatment options including durable mechanical circulatory support or heart transplant. The hub have 7/24 Shock Team on-site supplied with a protocol how to proceed with spoke transferred patients including decision making on which mechanical circulatory support implant with subsequent de-escalation or escalation pathway.

Detailed Description
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LSCSI is a Hub&Spoke project with the main aim to improve the outcome of patients with cardiogenic shock in Lower Silesia region, Poland. It consists of one hub which is Wroclaw University Hospital and eleven spokes which are eleven cardiology departments situated in Lower Silesian Voivodeship. The consortium have unified protocol defining which cardiogenic shock patient and when should be transferred to the hub for enhanced treatment options including durable mechanical circulatory support or heart transplant. Shared cardiogenic shock definition: Systolic blood pressure < 90 mmHg for > 30 minutes or need for vasopressors use to maintain systolic blood pressure > 90 mmHg Lactate level > 2.0 mmol/L Pulmonary capillary wedge pressure or left ventricle end diastolic pressure > 15 mmHg (excluding pulmonary embolism) Cardiac Index ≤ 2.2 l/min/m2 Diuresis < 30 ml/h Clinical signs of peripheral hypoperfusion Data required by hub from spoke Echocardiography with data on left and right ventricle function Current aortic and mixed venous blood gases Pulmonary artery catheter measurements including calculation of cardiac power, pulmonary artery pulsatile index, cardiac output, cardiac index, pulmonary artery wedge pressure, pulmonary vascular resistance, systemic vascular resistance (excluding pulmonary embolism) Peripheral blood tests including liver and kidney function, morphology, troponin, natriuretic peptides Currently used and possible for use vascular accesses For pulmonary embolism: computed tomography of pulmonary arteries Upon telephone contact hub shock team decides on patients transfer or further treatment in spoke facility. When decision on transfer is taken shock team members gather at emergency room when patient arrives and decides on treatment options according to shock team protocol. As a hub Wroclaw University Hospital provides mechanical circulatory support (Intra-aortic balloon pump, Impella CP (Cardiac Power), Impella 5.0, Impella RP (Right Pump), ECMO (ExtraCorporeal Membrane Oxygenation), Levitronix, HeartMate3) together with heart transplant program as a regional reference center for advanced heart failure patients. Additionally for acute pulmonary embolism complicated by shock hub provides peripheral or local thrombolysis and in case of contraindication for thrombolysis - transcatheter thrombectomy or surgical embolectomy.

Official Title
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Coordinated Treatment of Cardiogenic Shock Patients in Lower Silesia, Poland

Conditions
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Cardiogenic Shock

Intervention / Treatment
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* Procedure: Structured treatment of cardiogenic shock patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fulfilled definition of cardiogenic shock Age 18 - 60 years Shock duration below 24 hours Exclusion Criteria: History of cardiac arrest with anoxemic brain injury Irreversible multiorgan failure End stage of chronic diseases other than heart failure Neoplastic disease Lack of vascular access

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Structured treatment of cardiogenic shock patients|Creation of hub&spoke structure which covers all Lower Silesian Voivodeship (Poland) for treatment of cardiogenic shock patients. Based on shared protocol patients are reported to hub by spoke and decision is made as for patient transfer or further treatment in the spoke facility. If decision on transfer is made, patient is further treated according to hub on site shock team protocol|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-days all-cause mortality | All-cause mortality | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-months mortality | All-cause mortality | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECMO, Cardiogenic shock, Heart transplant, Mechanical circulatory support, Impella