Study of Multistep Pharmacological and Invasive Management for Cardiogenic Shock

Phase 2

Completed

• Conditions: Cardiogenic Shock
• Interventions: Drug: adrenaline

• Registration Number: NCT02591771
• Lead Sponsor: Niguarda Hospital

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 Description

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-11
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Primary Completion: 2017-07-25
• Study Completion: 2017-12-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adrenaline	adrenaline	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

Primary Outcome Measures

Name	Time	Method
Survival at 60 days	60 days	number of successes

Secondary Outcome Measures

Name	Time	Method
Adrenaline maximum dose	30 days
Length of stay	30 days
Duration of i.v. infusion with adrenaline	30 days
Time to weaning from beginning with pharmacological therapy and mechanical ventricular support	30 days
Sum of medical staff support and nursing-care hours dedicated to each patient	Within patient hospitalization, each day from day 1 to day 30
Membrane oxygenation	60 days	Escalation to venoarterial extracorporeal membrane oxygenation (VA-ECMO)

Trial Locations

Locations (2)

Niguarda Hospital; 🇮🇹 Milan, MI, Italy

Ospedale San Raffaele; 🇮🇹 Milano, Italy