Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05465200

Lower Silesia Cardiogenic Shock Initiative

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Heart Disease of Wroclaw Medical University

Wroclaw, 50-556, Poland

Location status: Recruiting

Location contact

Mateusz Sokolski, MD PhD

CONTACT

[email protected]

+48717331112

Mateusz Sokolski, MD PhD

SUB_INVESTIGATOR

Wiktor Kuliczkowski, MD PD

CONTACT

[email protected]

+48717331112

Wiktor Kuliczkowski, MD PD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured treatment of cardiogenic shock patients

Procedure

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

Primary outcomes

  1. 30-days all-cause mortality

    Time frame: 30 days

    All-cause mortality

Secondary outcomes

  1. 12-months mortality

    Time frame: 12 months

    All-cause mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Mateusz Sokolski

CONTACT

[email protected]

+48717331112

Wiktor Kuliczkowski

CONTACT

[email protected]

+48717331112

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

Coordinated Treatment of Cardiogenic Shock Patients in Lower Silesia, Poland

Acronym: LSCSI

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jul 19, 2022
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.