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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Central Hospital, Nancy, France
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01367743
First received: May 10, 2011
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Cardiogenic Shock
Drug: epinephrine/norepinephrine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • Compared effects of investigated drugs on cardiac index [ Time Frame: participants will be followed until release from ICU, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
    effectiveness of the treatment assessed by the evolution of cardiac index


Secondary Outcome Measures:
  • Compared effects of investigated drugs on heart rate and cardiac power index [ Time Frame: participants will be followed until release from ICU, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • pro/anti-inflammatory cytokines [ Time Frame: participants will be followed until release from ICU, an expected average of 2 weeks ] [ Designated as safety issue: No ]
    establish the pro/anti-inflammatory profile of cardiogenic shock in terms of cytokines and its evolution


Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: epinephrine Drug: epinephrine/norepinephrine
perfusion of commercial epinephrine or norepinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg
Other Names:
  • vasopressor
  • catecholamine
Active Comparator: norepinephrine Drug: epinephrine/norepinephrine
perfusion of commercial epinephrine or norepinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg
Other Names:
  • vasopressor
  • catecholamine

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367743

Contacts
Contact: LEVY Bruno, Doctor +33 3 83 15 44 69 b.levy@chu-nancy.fr
Contact: GIBOT Sebastien, Doctor +33 3 83 85 42 70 s.gibot@chu-nancy.fr

Locations
France
Nancy Brabois university hospital Recruiting
Vandoeuvre les Nancy, Meurthe et Moselle, France, 54500
Contact: Levy Bruno, PhD    +33 3 83 15 44 69    b.levy@chu-nancy.fr   
Contact: Gibot Sebastien, PhD    +33 3 83 15 29 70    s.gibot@chu-nancy.fr   
Principal Investigator: LEVY Bruno, Pr         
CHU de BESANCON / Hôpital Jean Minjoz Not yet recruiting
Besancon, France, 25030
Contact: CAPELLIER Gilles, Pr         
Principal Investigator: CAPELLIER Gilles, Dr         
CHU de DIJON Recruiting
Dijon, France, 21079
Contact: QUENOT Jean Pierre, Dr         
Principal Investigator: QUENOT Jean Pierre, Dr         
CHU de LIMOGES Hôpital Dupuytren Recruiting
Limoges, France, 87042
Contact: Vignon Philippe, Pr         
Principal Investigator: VIGNON Philippe, Pr         
APHM Hôpital NORD Recruiting
Marseille, France, 13015
Contact: LEONE Marc, Pr         
Principal Investigator: LEONE Marc, Pr         
Chr Metz Thionville Recruiting
Metz, France, 57000
Contact: LOUIS Guillaume, Dr         
Principal Investigator: LOUIS Guillaume, Dr         
CH de MULHOUSE Recruiting
Mulhouse, France, 68070
Contact: GUIOT Philippe, Dr         
Principal Investigator: GUIOT Philippe, Dr         
AP-HP-Hôpital Cochin Recruiting
Paris, France, 75014
Contact: Cariou Alain, Dr         
Principal Investigator: CARIOU Alain, Pr         
CHU de STRASBOURG / NHC Recruiting
Strasbourg, France, 67091
Contact: MEZIANI Ferhat, Pr         
Principal Investigator: MEZIANI Ferhat, Pr         
Chru Tours Recruiting
Tours, France, 37044
Contact: LEGRAS Annick, Dr         
Principal Investigator: LEGRAS Annick, Dr         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Philippe VIGNON, Dr CHU Limoges
  More Information

No publications provided

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01367743     History of Changes
Other Study ID Numbers: 2009-017081-23
Study First Received: May 10, 2011
Last Updated: June 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Central Hospital, Nancy, France:
myocardial infarction
epinephrine
norepinephrine
cardiac output

Additional relevant MeSH terms:
Myocardial Infarction
Shock
Shock, Cardiogenic
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Epinephrine
Epinephryl borate
Norepinephrine
Racepinephrine
Vasoconstrictor Agents
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014