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

May 10, 2011
June 24, 2014
September 2011
September 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01367743 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cardiogenic Shock
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: epinephrine
    Intervention: Drug: epinephrine/norepinephrine
  • Active Comparator: norepinephrine
    Intervention: Drug: epinephrine/norepinephrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
September 2016
September 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
France
 
NCT01367743
2009-017081-23
Yes
Central Hospital, Nancy, France
Central Hospital, Nancy, France
Not Provided
Principal Investigator: Philippe VIGNON, Dr CHU Limoges
Central Hospital, Nancy, France
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP