Lower Silesia Cardiogenic Shock Initiative

Cardiogenic Shock Clinical Trial

— LSCSI  

Official title:

Coordinated Treatment of Cardiogenic Shock Patients in Lower Silesia, Poland

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05465200
• Other study ID #: WMU012021
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 1, 2028

Study information

• Verified date: June 2024
• Source: Wroclaw Medical University
• Contact: Wiktor Kuliczkowski
• Phone: +48717331112
• Email: wiktor.kuliczkowski[@]umed.wroc.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

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

Locations

Country	Name	City	State
Poland	Institute of Heart Disease of Wroclaw Medical University	Wroclaw	Borowska 213

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-days all-cause mortality	All-cause mortality	30 days
Secondary	12-months mortality	All-cause mortality	12 months