Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The efficacy and tolerability of norepinephrine and epinephrine in cardiogenic shock after reperfused myocardial infarction will be compared, by following cardiac index evolution as main criteria. The study is a pilot pathophysiological study, randomized, double blind and multicenter.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Hospital, Nancy, France
• Treatments: Epinephrine; Epinephryl borate; Norepinephrine; Racepinephrine; Vasoconstrictor Agents

Criteria

Inclusion Criteria:

• man or woman older than 18 years

• cardiogenic shock due to myocardial infarction treated by angioplasty

• SAP < 90 MM Hg or MAP < 65 mm Hg without vasopressor or vasopressor necessity

• sign of tissue hypoperfusion

• cardiac index < 2.2 l/mn/m2 in the absence of vasopressive or inotropic therapy

• pulmonary artery occlusion pressure > 15 mmHg or echocardiographic evidence of high pressure (mitral profile)

• exclusion of covert hypovolemia : Delta PP if feasible should be > 13% (patient adapted to the ventilator and sinus rhythm) and /or no response to passive leg raising

• ejection fraction < 40% in ultrasound without inotrope support. This criteria will not be taken into account in instances of treatment with dopamine, norepinephrine, epinephrine, dobutamine or milrinone.

Exclusion Criteria:

• shock of other origin

• immediate indications for mechanical assistance device

• minor aged patients

• patients for whom written consent - by patient or family - has not been obtained. Given the seriousness of the medical situation at the time of inclusion, patient consent will be difficult if not impossible to obtain. The inclusion will only be possible after information is provided and consent is obtained from a family member. As soon as possible, protocol information will be issued to the patient in order to obtain consent for continuance.

• cardiac arrest with early signs of cerebral anoxia.

• septic, toxic and obstructive cardiomyopathy

• arrhythmogenic cardiomyopathy

• patient with coronary insufficiency

• patient with ventricular rhythm disorders

• patient treated with a medicine listed in contre indication

• patient without social assurance

• patient major under legal protection or safeguard justice