PHASE II CLINICAL TRIAL FOR A STEPWISE PROGRESSION IN THE TREATMENT OF CARDIOGENIC SHOCK

Phase 1

Conditions: Patients affected by cardiogenic shock
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2014-002672-86-IT

Lead Sponsor: AO OSPEDALE NIGUARDA CA' GRANDA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 24

Inclusion Criteria

Age = 18, males and females
Eligible patients have to fit at least TWO of the following criteria/items:
• SBP < 100 mmHg or MAP < 60 mmHg, after fluid challenge (at least 1000 ml of a crystalloid solution or 500 ml of a colloidal solution with right atrial pressure > 4 mmHg) or with a CVP > 12 mmHg or WCP >14 mmHg.
• Mixed venous oxygen saturation < 60%
• Arterial lactates > 2
• Oliguria < 0.5 ml/Kg/h
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Pregnant, lactating or subjects planning pregnancy during the course of the trial.
Participants involved in other clinical trial.
Ongoing major arrhythmias: VT or VF or AF, with ventricular rate > 160 bpm
inability to sign the informed consent
Low output state due to hypovolemia (right atrial pressure <4 mmHg)
Septic shock
Severe Aortic or mitral stenosis
Obstructive hypertrophic cardiomiopathy or constrictive pericarditis or severe congenital cardiomiopathy
Comorbidities with ominous prognosis (life expectancy < 1 year)
Overt infection, hepatic, renal or pulmonary dysfunction, altered neurological status without clear prognosis after an acute cardiac arrest or following cardiogenic shock
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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: survival at 60 days;Secondary Objective: duration of i.v. infusion with adrenaline<br>adrenaline maximum dose<br>time to weaning from beginning with pharmacological therapy and mechanical ventricular support<br>length of stay<br>medical staff support and nursing-care hours<br>Safety endpoints:<br>absence of major ventricular arrhythmias<br>bleeding (3 and 5 according to BARC score);Primary end point(s): number of successes;Timepoint(s) of evaluation of this end point: 60 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): mean and median values will be calculated together with their 95% confidence intervals and with the more suitable dispersion measure (standard deviation or range);Timepoint(s) of evaluation of this end point: not applicable