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

Cardiogenic Shock Clinical Trial

— OptimaCC  

Official title:

Optimizing the Use of Vasopressor After Coronary Reperfusion in Cardiogenic Shock Secondary to Myocardial Infarction. Pathophysiological Study Comparing the Efficacy and Cardio-circulatory Tolerability of Epinephrine and Norepinephrine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367743
• Other study ID #: 2009-017081-23
• Status: Completed
• Phase: Phase 4
• Start date: September 2011
• Est. completion date: August 2016

Study information

• Verified date: January 2019
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cardiogenic shock secondary to myocardial infarction is a frequent pathology in reanimation and is associated with high mortality (50%). Hemodynamic management and notably the choice of vasopressor in cardiogenic shock states secondary to myocardial infarction (cardiac index < 2.2 l/min/m-2) is not codified. There are two opposite views: a) the first is based on the fact that an hypotensive patient with low cardiac output is primarily in need of an inotropic agent and that, consequently, epinephrine is the molecule of choice (inotropic and vasoconstrictor); b) the second is based on the fact that hypotension also reflects a certain degree of vascular failure and vascular vasoplegia and therefore norepinephrine is the molecule of choice along with, if needed, the eventual addition of dobutamine in order to separately titrate vasoconstriction and inotropism.

Study hypotheses: epinephrine could facilitate myocardial function by providing the latter with its preferred substrate (lactate) and thus induce a higher cardiac index along with increased energy expenditure. Norepinephrine is the therapy of choice of hypotensive states; nevertheless its lack of inotropic effect could theoretically exacerbate myocardial failure. Thus, the aim of the study is to compared the efficiency and the tolerability of norepinephrine and epinephrine in cardiogenic shock after reperfused myocardial infarction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Myocardial Infarction
• Shock
• Shock, Cardiogenic

Intervention

Drug:
• epinephrine perfusion
perfusion of commercial epinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg
• norepinephrine perfusion
perfusion of commercial norepinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg

Locations

Country	Name	City	State
France	CHU de BESANCON / Hôpital Jean Minjoz	Besancon
France	CHU de DIJON	Dijon
France	CHU de LIMOGES Hôpital Dupuytren	Limoges
France	APHM Hôpital NORD	Marseille
France	Chr Metz Thionville	Metz
France	CH de MULHOUSE	Mulhouse
France	AP-HP-Hôpital Cochin	Paris
France	CHU de STRASBOURG / NHC	Strasbourg
France	CHU Toulouse	Toulouse
France	Chru Tours	Tours
France	Nancy Brabois university hospital	Vandoeuvre les Nancy	Meurthe Et Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compared effects of investigated drugs on cardiac index	effectiveness of the treatment assessed by the evolution of cardiac index	H0; H2, H4, H6, H12, H24, H48 and H72
Secondary	pro/anti-inflammatory cytokines	Compared effects of investigated drugs on pro/anti-inflammatory cytokines	H0, H24, H48 and H72
Secondary	BNP	Compared effects of investigated drugs on BNP	H0, H24, H48 and H72
Secondary	Troponin	Compared effects of investigated drugs on Troponin	H0, H24, H48 and H72
Secondary	catecholamine doses	Compared effects of investigated drugs on the catecholamine doses	H0, H24, H48 and H72
Secondary	organ failure (SOFA Score)	Compared effects of investigated drugs on the organ failure	H0, H24, H48 and H72
Secondary	Lactate clearance	Compared effects of investigated drugs on the Lactate clearance	H0, H2, H6, H12, H24 and H48
Secondary	heart rate	Compared effects of investigated drugs on heart rate and the incidence of arrhythmia	H0, H2, H4, H6, H12, H24, H48 and H72
Secondary	cardiac power index	Compared effects of investigated drugs on cardiac power	H0, H2, H4, H6, H12, H24, H48 and H72.
Secondary	SVO2	Compared effects of investigated drugs on the SVO2	H0, H2, H4, H6, H12, H24, H48 and H72.
Secondary	cardiac double product	Compared effects of investigated drugs on the cardiac double product	H0, H2, H4, H6, H12, H24, H48 and H72.
Secondary	refractory cardiogenic shock	compared effects of the investigated drugs on the occurrence of refractory cardiogenic shock	H0, H2, H4, H6, H12, H24, H48 and H72.