Cardiogenic ShockLSCSINCT05465200
Lower Silesia Cardiogenic Shock Initiative
An observational study of Cardiogenic Shock, run by Wroclaw Medical University at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Structured treatment of cardiogenic shock patients
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2022to 1 Jan 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- Fulfilled definition of cardiogenic shock
- Age 18 - 60 years
- Shock duration below 24 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Institute of Heart Disease of Wroclaw Medical University
Wroclaw, 50-556
Wiktor Kuliczkowski, MD PD, +48717331112, wiktor.kuliczkowski@umed.wroc.pl
Mateusz Sokolski, MD PhD, +48717331112, mateusz.sokolski@umed.wroc.pl
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Cardiogenic Shock
- Being tested
- Structured treatment of cardiogenic shock patients
- Keywords
- Cardiogenic shock, ECMO, Heart transplant, Mechanical circulatory support, Impella
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured treatment of cardiogenic shock patientsProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
30-days all-cause mortality
All-cause mortality
Measured: 30 days
Secondary outcomes (1)
12-months mortality
All-cause mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wiktor Kuliczkowski, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465200
- Sponsor's protocol ID
- WMU012021
- Acronym
- LSCSI
- Status last verified
- Mar 2025
- First submitted
- 15 Jul 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Krupka D, Chelmonski A, Karska K, Mazur K, Cicirko K, Drewniowska J, Florek K, Grunwald K, Milewski M, Nnoli M, Ptak J, Blaziak M, Balcer B, Zymlinski R, Gozdzik W, Barteczko-Grajek B, Bochenek M, Przybylski R, Zakliczynski M, Kuliczkowski W, Sokolski M. Clinical characteristics of patients with cardiogenic shock after out-of-hospital cardiac arrest (OHCA) compared to patients with cardiogenic shock without OHCA. Cardiol J. 2026;33:e00226045. doi: 10.5603/cj.106691.
PubMed 42047026
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinated Treatment of Cardiogenic Shock Patients in Lower Silesia, Poland
- ClinicalTrials.gov ID
- NCT05465200
- Acronym / sponsor ID
- LSCSI / WMU012021
- Conditions
- Cardiogenic Shock
- Keywords
- Cardiogenic shock, ECMO, Heart transplant, Mechanical circulatory support, Impella
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- Fulfilled definition of cardiogenic shock
- Age 18 - 60 years
- Shock duration below 24 hours
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured treatment of cardiogenic shock patientsCreation 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 | Procedure or surgery | – |
Primary outcome
30-days all-cause mortality
Time frame: 30 days
All-cause mortality
1 secondary outcome
12-months mortality
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 42047026Krupka D, Chelmonski A, Karska K, Mazur K, Cicirko K, Drewniowska J, Florek K, Grunwald K, Milewski M, Nnoli M, Ptak J, Blaziak M, Balcer B, Zymlinski R, Gozdzik W, Barteczko-Grajek B, Bochenek M, Przybylski R, Zakliczynski M, Kuliczkowski W, Sokolski M. Clinical characteristics of patients with cardiogenic shock after out-of-hospital cardiac arrest (OHCA) compared to patients with cardiogenic shock without OHCA. Cardiol J. 2026;33:e00226045. doi: 10.5603/cj.106691.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wiktor Kuliczkowski (+48717331112, wiktor.kuliczkowski@umed.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-days all-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05465200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.