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

Information source: Central Hospital, Nancy, France
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiogenic Shock

Intervention: epinephrine/norepinephrine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Central Hospital, Nancy, France

Official(s) and/or principal investigator(s):
Philippe VIGNON, Dr, Principal Investigator, Affiliation: CHU Limoges

Overall contact:
LEVY Bruno, Doctor, Phone: +33 3 83 15 44 69, Email: b.levy@chu-nancy.fr

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Compared effects of investigated drugs on cardiac index

Secondary outcome:

Compared effects of investigated drugs on heart rate and cardiac power index

pro/anti-inflammatory cytokines

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

- sign of tissue hypoperfusion

- cardiac index < 2. 2 l/mn/m2 in the absence of vasopressive or inotropic therapy

- pulmonary artery occlusion pressure > 15 mm Hg 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

Locations and Contacts

LEVY Bruno, Doctor, Phone: +33 3 83 15 44 69, Email: b.levy@chu-nancy.fr

CHU de BESANCON / Hôpital Jean Minjoz, Besancon 25030, France; Not yet recruiting
CAPELLIER Gilles, Pr
CAPELLIER Gilles, Dr, Principal Investigator

CHU de DIJON, Dijon 21079, France; Recruiting
QUENOT Jean Pierre, Dr
QUENOT Jean Pierre, Dr, Principal Investigator

CHU de LIMOGES Hôpital Dupuytren, Limoges 87042, France; Recruiting
Vignon Philippe, Pr
VIGNON Philippe, Pr, Principal Investigator

APHM Hôpital NORD, Marseille 13015, France; Recruiting
LEONE Marc, Pr
LEONE Marc, Pr, Principal Investigator

Chr Metz Thionville, Metz 57000, France; Recruiting
LOUIS Guillaume, Dr
LOUIS Guillaume, Dr, Principal Investigator

CH de MULHOUSE, Mulhouse 68070, France; Recruiting
GUIOT Philippe, Dr
GUIOT Philippe, Dr, Principal Investigator

AP-HP-Hôpital Cochin, Paris 75014, France; Recruiting
Cariou Alain, Dr
CARIOU Alain, Pr, Principal Investigator

CHU de STRASBOURG / NHC, Strasbourg 67091, France; Recruiting
MEZIANI Ferhat, Pr
MEZIANI Ferhat, Pr, Principal Investigator

Chru Tours, Tours 37044, France; Recruiting
LEGRAS Annick, Dr
LEGRAS Annick, Dr, Principal Investigator

Nancy Brabois university hospital, Vandoeuvre les Nancy, Meurthe et Moselle 54500, France; Recruiting
Levy Bruno, PhD, Phone: +33 3 83 15 44 69, Email: b.levy@chu-nancy.fr
Gibot Sebastien, PhD, Phone: +33 3 83 15 29 70, Email: s.gibot@chu-nancy.fr
LEVY Bruno, Pr, Principal Investigator

Additional Information

Starting date: September 2011
Last updated: July 29, 2015

Page last updated: August 23, 2015

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