Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-29 @ 5:03 PM
Study NCT ID:
NCT05465200
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2022-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Silesia Cardiogenic Shock Initiative
Sponsor:
Wroclaw Medical University
Organization:
Study Overview
Official Title:
Coordinated Treatment of Cardiogenic Shock Patients in Lower Silesia, Poland
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LSCSI
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: