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NCT Number: NCT01367743

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nancy Brabois university hospital, Vandœuvre-lès-Nancy, Meurthe Et Moselle, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epinephrine perfusion

Drug

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

Other names: vasopressor, catecholamine

norepinephrine perfusion

Drug

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

Other names: vasopressor, catecholamine

Primary outcomes

  1. 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 outcomes

  1. pro/anti-inflammatory cytokines

    Time frame: H0, H24, H48 and H72

    Compared effects of investigated drugs on pro/anti-inflammatory cytokines

  2. BNP

    Time frame: H0, H24, H48 and H72

    Compared effects of investigated drugs on BNP

  3. Troponin

    Time frame: H0, H24, H48 and H72

    Compared effects of investigated drugs on Troponin

  4. catecholamine doses

    Time frame: H0, H24, H48 and H72

    Compared effects of investigated drugs on the catecholamine doses

  5. organ failure (SOFA Score)

    Time frame: H0, H24, H48 and H72

    Compared effects of investigated drugs on the organ failure

  6. Lactate clearance

    Time frame: H0, H2, H6, H12, H24 and H48

    Compared effects of investigated drugs on the Lactate clearance

  7. 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

  8. cardiac power index

    Time frame: H0, H2, H4, H6, H12, H24, H48 and H72.

    Compared effects of investigated drugs on cardiac power

  9. SVO2

    Time frame: H0, H2, H4, H6, H12, H24, H48 and H72.

    Compared effects of investigated drugs on the SVO2

  10. cardiac double product

    Time frame: H0, H2, H4, H6, H12, H24, H48 and H72.

    Compared effects of investigated drugs on the cardiac double product

  11. 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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

Acronym: OptimaCC

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jun 7, 2011
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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