Clinical Trial: Study of Multistep Pharmacological and Invasive Management for Cardiogenic Shock
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase II Clinical Trial for a Stepwise Progression in the Treatment of Cardiogenic Shock
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Niguarda Hospital
Current Primary Outcome: Survival at 60 days [ Time Frame: 60 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Niguarda Hospital
Dates:
Date Received: October 11, 2015
Date Started: October 2015
Date Completion: September 1, 2017
Last Updated: March 31, 2017
Last Verified: March 2017