Study of Multistep Pharmacological and Invasive Management for Cardiogenic Shock

Cardiogenic Shock Clinical Trial

Official title:

Phase II Clinical Trial for a Stepwise Progression in the Treatment of Cardiogenic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591771
• Other study ID #: AltShock
• Status: Completed
• Phase: Phase 2
• Start date: October 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2021
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2017
• Est. primary completion date: July 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Age = 18 and < 75, men and women;

• 1) SBP < 90mmHg or 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.

• Pre-existing diagnosis of heart failure with 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: 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 HRT.

Exclusion Criteria

• 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.

• Post-cardiac arrest syndrome following out of hospital cardiac arrest

• Comorbidities with ominous prognosis (life expectancy < 1 year).

• End-stage organ failure.

• 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.

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Italy	Niguarda Hospital	Milan	MI
Italy	Ospedale San Raffaele	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Niguarda Hospital	Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Morici N, Oliva F, Ajello S, Stucchi M, Sacco A, Cipriani MG, De Bonis M, Garascia A, Gagliardone MP, Melisurgo G, Russo CF, La Vecchia C, Frigerio M, Pappalardo F. Management of cardiogenic shock in acute decompensated chronic heart failure: The ALTSHOCK — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at 60 days	number of successes	60 days
Secondary	Duration of i.v. infusion with adrenaline		30 days
Secondary	Adrenaline maximum dose		30 days
Secondary	Time to weaning from beginning with pharmacological therapy and mechanical ventricular support		30 days
Secondary	Length of stay		30 days
Secondary	Sum of medical staff support and nursing-care hours dedicated to each patient		Within patient hospitalization, each day from day 1 to day 30
Secondary	Membrane oxygenation	Escalation to venoarterial extracorporeal membrane oxygenation (VA-ECMO)	60 days