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临床试验/NCT01367743
NCT01367743已完成4 期

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

Central Hospital, Nancy, France11 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
58
试验地点
11
主要终点
Compared effects of investigated drugs on cardiac index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

epinephrine

Active Comparator

干预措施: epinephrine perfusion (Drug)

norepinephrine

Active Comparator

干预措施: norepinephrine perfusion (Drug)

结局指标

主要结局

Compared effects of investigated drugs on cardiac index

时间窗: H0; H2, H4, H6, H12, H24, H48 and H72

effectiveness of the treatment assessed by the evolution of cardiac index

次要结局

  • Troponin(H0, H24, H48 and H72)
  • cardiac power index(H0, H2, H4, H6, H12, H24, H48 and H72.)
  • pro/anti-inflammatory cytokines(H0, H24, H48 and H72)
  • organ failure (SOFA Score)(H0, H24, H48 and H72)
  • Lactate clearance(H0, H2, H6, H12, H24 and H48)
  • heart rate(H0, H2, H4, H6, H12, H24, H48 and H72)
  • cardiac double product(H0, H2, H4, H6, H12, H24, H48 and H72.)
  • refractory cardiogenic shock(H0, H2, H4, H6, H12, H24, H48 and H72.)
  • BNP(H0, H24, H48 and H72)
  • catecholamine doses(H0, H24, H48 and H72)
  • SVO2(H0, H2, H4, H6, H12, H24, H48 and H72.)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (11)

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