The purpose of this study is to evaluate efficacy and safety of i.v. adrenaline infusion as an early and fast haemodynamic stabilizer, associated with a tight tissue perfusion monitoring, in the context of a stepwise progression in the treatment of cardiogenic shock, including ventricular mechanical support.
Cardiogenic shock is characterized by a decrease in cardiac output and increased ventricular pressures, with subsequent symptoms and signs of systemic hypoperfusion. In spite of the multiple pharmacological chances the in-hospital mortality rate is still very high (around 60% of patients) and nowadays there is not a therapeutic "reference standard" associated with an improved survival at short and midterm. Adrenaline is a mainstay of resuscitation therapy during cardiopulmonary arrest, however, it is not clear whether this inotrope actually facilitates an improvement in patients affected by cardiogenic shock. In a small local evidence-based experience, contrary to current opinion, it has been shown that adrenaline may still have a role in the treatment of patients with low output state. This phase II study tests the hypothesis that adrenaline infusion, integrated in a multistep approach at increasing intensity, can be a valid support with limited side effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
i.v. adrenaline infusion as an early and fast haemodynamic stabilizer, associated with a tight tissue perfusion monitoring, in the context of a stepwise progression in the treatment of cardiogenic shock, including ventricular mechanical support
Niguarda Hospital
Milan, MI, Italy
Ospedale San Raffaele
Milan, Italy
Survival at 60 days
number of successes
Time frame: 60 days
Duration of i.v. infusion with adrenaline
Time frame: 30 days
Adrenaline maximum dose
Time frame: 30 days
Time to weaning from beginning with pharmacological therapy and mechanical ventricular support
Time frame: 30 days
Length of stay
Time frame: 30 days
Sum of medical staff support and nursing-care hours dedicated to each patient
Time frame: Within patient hospitalization, each day from day 1 to day 30
Membrane oxygenation
Escalation to venoarterial extracorporeal membrane oxygenation (VA-ECMO)
Time frame: 60 days
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