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Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock

ConditionCardiogenic Shock
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWroclaw Medical University

About this trial

The registry objective is to get information on current epidemiology, diagnostics, treatment and outcome in patients with cardiogenic shock in Poland. Obtained information will help to plan the nationwide initiative for modern cardiogenic shock treatment with established place for mechanical circulatory support.

It is hypothesized that the treatment and outcome of cardiogenic shock, including mechanical circulatory support, are currently poor in Poland and should be improved. Unfortunately, without status quo data, efficient planning for its improvement cannot be conducted, hence the CaS-POL registry initiative.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cardiogenic shock patients of all etiologies in SCAI stage B, C, D, E.

age > 18 years old

persistent hemodynamic failure defined as systolic blood pressure of <90 mmHg for ≥ 30 minutes or the requirement for inotropic or vasopressor agents with evidence of hypoperfusion of the peripheral organs

Disqualifiers

patients without return of spontaneous circulation who were considered to extracorporeal cardiopulmonary resuscitation (ECPR)

primary septic, anaphylactic, hypovolemic shock

post-operative cardiogenic shock

end-stage of heart failure disqualified from mechanical circulatory support and heart transplantation

Trial population

All patients admitted to the Intensive Care Unit (ICU) in the Cardiology, Cardiac Surgery, or to the Anesthesiology departments with a clinically evident cardiac etiology of shock.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 1 trial group
Group A: cardiogenic shock patients

Trial outcomes

Primary outcomes

1

all-cause mortality

all-cause mortality

Time frame
From the date of cardiogenic shock diagnosis recognition until the date of death from any cause assessed up to 6 months

Secondary outcomes

1

myocardial infarction

Recurrent myocardial infarction following an initial event

Time frame
From the date of cardiogenic shock diagnosis recognition until the date of first documented myocardial infarction assessed up to 6 months
2

stroke

stroke following an initial event

Time frame
From the date of cardiogenic shock diagnosis recognition until the date of first documented stroke assessed up to 6 months
3

heart transplantation

Heart transplantation in patients without myocardial recovery following cardiogenic shock.

Time frame
From the date of cardiogenic shock diagnosis recognition until the date of heart transplantation assessed up to 6 months
4

long-term LVAD implantation

Long-term LVAD implantation in patients without myocardial recovery following cardiogenic shock

Time frame
From the date of cardiogenic shock diagnosis recognition until the date of long-term LVAD assessed up to 6 months

Other outcomes

Sponsors and contacts

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

Wroclaw Medical University

Lead sponsor

Polish Cardiac Society

Collaborator

Johnson & Johnson

Collaborator

Source ClinicalTrials.gov
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