Status:
UNKNOWN
Cardiogenic Shock Integrated PHenotyping for Event Reduction
Lead Sponsor:
Niguarda Hospital
Conditions:
Heart Failure
Eligibility:
All Genders
18-74 years
Brief 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 evalu...
Detailed Description
Cardiogenic shock (CS) is a heterogenous syndrome with in-hospital mortality up to 60%, that, unfortunately, has remained stagnant over the time, despite observed improvements with pharmacological and...
Eligibility Criteria
Inclusion
- 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
- 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.
- Comorbidities with ominous prognosis (life expectancy \< 1 year).
- Estimated glomerular filtration rate severely impaired before enrolment (eGFR\<30 ml/min/1.73 m2) or severe chronic obstructive pulmonary disease (COPD) or liver cirrhosis.
- Pregnant, lactating or subjects planning pregnancy during the course of the trial.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Key Trial Info
Start Date :
June 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04323371
Start Date
June 30 2020
End Date
March 1 2025
Last Update
March 22 2023
Active Locations (1)
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1
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162