LSCSI: Lower Silesia Cardiogenic Shock Initiative

• Sponsor: Wroclaw Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05465200
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Coordinated Treatment of Cardiogenic Shock Patients in Lower Silesia, Poland
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2027
• Anticipated Study Completion Date: Jan 1, 2028

Outcome Measures

Primary Outcome Measures

1. 30-days all-cause mortality [30 days]

   All-cause mortality

Secondary Outcome Measures

1. 12-months mortality [12 months]

   All-cause mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Heart Disease of Wroclaw Medical University	Wroclaw	Borowska 213	Poland	50-556

Sponsors and Collaborators

• Wroclaw Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wiktor Kuliczkowski, Head of Catheterization Laboratory, Wroclaw Medical University
• ClinicalTrials.gov Identifier: NCT05465200
• Other Study ID Numbers: WMU012021
• First Posted: Jul 19, 2022
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wiktor Kuliczkowski, Head of Catheterization Laboratory, Wroclaw Medical University: Cardiogenic shock; ECMO; Heart transplant; Mechanical circulatory support; Impella
• Additional relevant MeSH terms: Shock, Cardiogenic; Shock

Study Results

No Results Posted as of Aug 24, 2022