We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367743
First Posted: June 7, 2011
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Central Hospital, Nancy, France
  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 perfusion Drug: norepinephrine perfusion Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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: H0; H2, H4, H6, H12, H24, H48 and H72 ]
    effectiveness of the treatment assessed by the evolution of cardiac index


Secondary Outcome Measures:
  • pro/anti-inflammatory cytokines [ Time Frame: H0, H24, H48 and H72 ]
    Compared effects of investigated drugs on pro/anti-inflammatory cytokines

  • BNP [ Time Frame: H0, H24, H48 and H72 ]
    Compared effects of investigated drugs on BNP

  • Troponin [ Time Frame: H0, H24, H48 and H72 ]
    Compared effects of investigated drugs on Troponin

  • catecholamine doses [ Time Frame: H0, H24, H48 and H72 ]
    Compared effects of investigated drugs on the catecholamine doses

  • organ failure (SOFA Score) [ Time Frame: H0, H24, H48 and H72 ]
    Compared effects of investigated drugs on the organ failure

  • Lactate clearance [ Time Frame: H0, H2, H6, H12, H24 and H48 ]
    Compared effects of investigated drugs on the Lactate clearance

  • heart rate [ Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72 ]
    Compared effects of investigated drugs on heart rate and the incidence of arrhythmia

  • cardiac power index [ Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72. ]
    Compared effects of investigated drugs on cardiac power

  • SVO2 [ Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72. ]
    Compared effects of investigated drugs on the SVO2

  • cardiac double product [ Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72. ]
    Compared effects of investigated drugs on the cardiac double product

  • refractory cardiogenic shock [ Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72. ]
    compared effects of the investigated drugs on the occurrence of refractory cardiogenic shock


Enrollment: 58
Study Start Date: September 2011
Study Completion Date: August 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: epinephrine Drug: epinephrine perfusion
perfusion of commercial epinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg
Other Names:
  • vasopressor
  • catecholamine
Active Comparator: norepinephrine Drug: norepinephrine perfusion
perfusion of commercial 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367743


Locations
France
Nancy Brabois university hospital
Vandoeuvre les Nancy, Meurthe et Moselle, France, 54500
CHU de BESANCON / Hôpital Jean Minjoz
Besancon, France, 25030
CHU de DIJON
Dijon, France, 21079
CHU de LIMOGES Hôpital Dupuytren
Limoges, France, 87042
APHM Hôpital NORD
Marseille, France, 13015
Chr Metz Thionville
Metz, France, 57000
CH de MULHOUSE
Mulhouse, France, 68070
AP-HP-Hôpital Cochin
Paris, France, 75014
CHU de STRASBOURG / NHC
Strasbourg, France, 67091
CHU Toulouse
Toulouse, France
Chru Tours
Tours, France, 37044
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Philippe VIGNON, Dr CHU Limoges
  More Information

Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01367743     History of Changes
Other Study ID Numbers: 2009-017081-23
First Submitted: May 10, 2011
First Posted: June 7, 2011
Last Update Posted: April 24, 2017
Last Verified: April 2017

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

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