Lower Silesia Cardiogenic Shock Initiative

ConditionCardiogenic Shock

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-60

SponsorWroclaw Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fulfilled definition of cardiogenic shock

Age 18 - 60 years

Shock duration below 24 hours

Disqualifiers

History of cardiac arrest with anoxemic brain injury

Irreversible multiorgan failure

End stage of chronic diseases other than heart failure

Neoplastic disease

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Structured treatment of cardiogenic shock patients
Procedure/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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

30-days all-cause mortality

All-cause mortality

Time frame

30 days

Secondary outcomes

12-months mortality

All-cause mortality

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wroclaw Medical University

Lead sponsor

Source ClinicalTrials.gov

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