Cardiogenic Shock Integrated PHenotyping for Event Reduction
Italy26 participantsStarted 2020-06-30
Plain-language summary
The purpose of this study is to better understand the time course of different biological mechanisms involved in acute decompensated heart failure complicated by cardiogenic shock throughout the evaluation of changes and the relationship among markers of inflammation (IL-6) and markers of increased endothelial permeability (Ang-2) or endothelial glycocalyx perturbation (Syndecan-1 and HS) and throughout a targeted metabolomic approach.
Who can participate
Age range18 Years – 74 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 and \< 75, men and women;
* 1\) Systolic blood pressure (SBP) \< 90mmHg or mean arterial pressure (MAP) \< 60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload; OR 2) need of vasoactive agents to maintain SBP \> 90 mmHg or MAP \> 60 mmHg.
* Reduced ejection fraction (left ventricle systolic function ≤35%).
* Moreover, eligible patients have to fit at least ONE of the following criteria/items of overt hypoperfusion: altered state of consciousness; sweaty and cold skin; mixed venous oxygen saturation \< 60%; arterial lactates \> 2 mmol/L; oliguria \< 0.5 ml/Kg/h for at least 6 hours.
* Eligible patients shouldn't have contraindications to heart replacement therapy (HRT).
Exclusion Criteria:
The participant will not be enrolled if ANY of the following criteria will be detected:
* Cardiogenic shock symptoms beyond 6 hours.
* Septic shock with evident septic focus.
* Cardiogenic shock due to acute myocardial infarction.
* Cardiogenic shock due to acute myocarditis.
* Cardiogenic shock due to pulmonary thromboembolism.
* Reiterating major arrhythmias: VT or VF or AF, with ventricular rate \> 160 bpm.
* Severe aortic valve disease.
* Obstructive hypertrophic cardiomyopathy or constrictive pericarditis or severe heart failure due to congenital heart disease
* Severe peripheral vascular disease that contraindicates mechanical support insertion.
* Cardiogenic shock secondary to either cardiac or non-cardiac surgery…