Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock (OptimaCC)
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| First Received Date ICMJE | May 10, 2011 | ||||||||
| Last Updated Date | August 28, 2012 | ||||||||
| Start Date ICMJE | July 2011 | ||||||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01367743 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief Summary | 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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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Cardiogenic Shock | ||||||||
| Intervention ICMJE | Drug: epinephrine/norepinephrine
perfusion of commercial epinephrine or norepinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg
Other Names:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | July 2014 | ||||||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01367743 | ||||||||
| Other Study ID Numbers ICMJE | 2009-017081-23 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Central Hospital, Nancy, France | ||||||||
| Study Sponsor ICMJE | Central Hospital, Nancy, France | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Central Hospital, Nancy, France | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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