Patients affected by cardiogenic shock
Conditions
Interventions
Product Name: Adrenalina
Product Code: Adrenalina
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: na
CAS Number: 51-43-4
Current Sponsor code: na
Other descriptive name: EPINEPHRINE
Co
Sponsors
AO OSPEDALE NIGUARDA CA' GRANDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18, males and females Eligible patients have to fit at least TWO of the following criteria/items: • SBP 4 mmHg) or with a CVP > 12 mmHg or WCP >14 mmHg. • Mixed venous oxygen saturation 2 • Oliguria =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: survival at 60 days;Secondary Objective: duration of i.v. infusion with adrenaline adrenaline maximum dose time to weaning from beginning with pharmacological therapy and mechanical ventricular support length of stay medical staff support and nursing-care hours Safety endpoints: absence of major ventricular arrhythmias 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactDr Fabrizio Oliva
dipartimento cardiotoracovascolare UTIC
Outcome results
None listed