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Lower Silesia Cardiogenic Shock Initiative

Coordinated Treatment of Cardiogenic Shock Patients in Lower Silesia, Poland

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05465200
Acronym
LSCSI
Enrollment
50
Registered
2022-07-19
Start date
2022-01-01
Completion date
2028-01-01
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiogenic Shock

Keywords

Cardiogenic shock, ECMO, Heart transplant, Mechanical circulatory support, Impella

Brief summary

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

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: 1. Systolic blood pressure \< 90 mmHg for \> 30 minutes or need for vasopressors use to maintain systolic blood pressure \> 90 mmHg 2. Lactate level \> 2.0 mmol/L 3. Pulmonary capillary wedge pressure or left ventricle end diastolic pressure \> 15 mmHg (excluding pulmonary embolism) 4. Cardiac Index ≤ 2.2 l/min/m2 5. Diuresis \< 30 ml/h 6. Clinical signs of peripheral hypoperfusion Data required by hub from spoke 1. Echocardiography with data on left and right ventricle function 2. Current aortic and mixed venous blood gases 3. 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) 4. Peripheral blood tests including liver and kidney function, morphology, troponin, natriuretic peptides 5. Currently used and possible for use vascular accesses 6. 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.

Interventions

PROCEDUREStructured 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

Sponsors

Wroclaw Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Fulfilled definition of cardiogenic shock 2. Age 18 - 60 years 3. Shock duration below 24 hours

Exclusion criteria

1. History of cardiac arrest with anoxemic brain injury 2. Irreversible multiorgan failure 3. End stage of chronic diseases other than heart failure 4. Neoplastic disease 5. Lack of vascular access

Design outcomes

Primary

MeasureTime frameDescription
30-days all-cause mortality30 daysAll-cause mortality

Secondary

MeasureTime frameDescription
12-months mortality12 monthsAll-cause mortality

Countries

Poland

Contacts

Primary ContactWiktor Kuliczkowski
wiktor.kuliczkowski@umed.wroc.pl+48717331112
Backup ContactMateusz Sokolski
mateusz.sokolski@umed.wroc.pl+48717331112

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026