Lower Silesia Cardiogenic Shock Initiative (LSCSI)

Coordinated Treatment of Cardiogenic Shock Patients in Lower Silesia, Poland

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiogenic Shock
• Intervention / Treatment: Procedure: Structured treatment of cardiogenic shock patients

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Wiktor Kuliczkowski; Phone Number: +48717331112; Email: wiktor.kuliczkowski@umed.wroc.pl
• Study Contact Backup: Name: Mateusz Sokolski; Phone Number: +48717331112; Email: mateusz.sokolski@umed.wroc.pl

Study Locations

• Poland
  • Wroclaw, Poland, 50-556
    • Recruiting
    • Institute of Heart Disease of Wroclaw Medical University
    • Contact: Wiktor Kuliczkowski, MD PD; Phone Number: +48717331112; Email: wiktor.kuliczkowski@umed.wroc.pl
    • Contact: Mateusz Sokolski, MD PhD; Phone Number: +48717331112; Email: mateusz.sokolski@umed.wroc.pl
    • Contact: Wiktor Kuliczkowski, MD PD
    • Contact: Mateusz Sokolski, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

LSCSI is designed to treat cardiogenic shock which may develop during:

1. Acute coronary syndrome
2. Acute decompensated heart failure
3. Acute myocarditis
4. Acute or decompensated chronic valvular heart disease
5. Takotsubo cardiomyopathy
6. Peripartum cardiomyopathy
7. Acute pulmonary embolism

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Heart transplant; ECMO; Impella; Cardiogenic shock; Mechanical circulatory support
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Shock, Cardiogenic; Shock
• Other Study ID Numbers: WMU012021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No