Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock
OptimaCC
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
1 other identifier
interventional
58
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2011
Longer than P75 for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
June 7, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFebruary 1, 2019
January 1, 2019
4.4 years
May 10, 2011
January 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compared effects of investigated drugs on cardiac index
effectiveness of the treatment assessed by the evolution of cardiac index
H0; H2, H4, H6, H12, H24, H48 and H72
Secondary Outcomes (11)
pro/anti-inflammatory cytokines
H0, H24, H48 and H72
BNP
H0, H24, H48 and H72
Troponin
H0, H24, H48 and H72
catecholamine doses
H0, H24, H48 and H72
organ failure (SOFA Score)
H0, H24, H48 and H72
- +6 more secondary outcomes
Study Arms (2)
epinephrine
ACTIVE COMPARATORnorepinephrine
ACTIVE COMPARATORInterventions
perfusion of commercial epinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg
perfusion of commercial norepinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg
Eligibility Criteria
You may qualify if:
- 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)
- 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.
You may not qualify if:
- shock of other origin
- immediate indications for mechanical assistance device
- minor aged patients
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Nancy Brabois university hospital
Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54500, France
CHU de BESANCON / Hôpital Jean Minjoz
Besançon, 25030, France
CHU de DIJON
Dijon, 21079, France
CHU de LIMOGES Hôpital Dupuytren
Limoges, 87042, France
APHM Hôpital NORD
Marseille, 13015, France
Chr Metz Thionville
Metz, 57000, France
CH de MULHOUSE
Mulhouse, 68070, France
AP-HP-Hôpital Cochin
Paris, 75014, France
CHU de STRASBOURG / NHC
Strasbourg, 67091, France
CHU Toulouse
Toulouse, France
Chru Tours
Tours, 37044, France
Related Publications (2)
Takagi K, Blet A, Levy B, Deniau B, Azibani F, Feliot E, Bergmann A, Santos K, Hartmann O, Gayat E, Mebazaa A, Kimmoun A. Circulating dipeptidyl peptidase 3 and alteration in haemodynamics in cardiogenic shock: results from the OptimaCC trial. Eur J Heart Fail. 2020 Feb;22(2):279-286. doi: 10.1002/ejhf.1600. Epub 2019 Aug 31.
PMID: 31472039DERIVEDLevy B, Clere-Jehl R, Legras A, Morichau-Beauchant T, Leone M, Frederique G, Quenot JP, Kimmoun A, Cariou A, Lassus J, Harjola VP, Meziani F, Louis G, Rossignol P, Duarte K, Girerd N, Mebazaa A, Vignon P; Collaborators. Epinephrine Versus Norepinephrine for Cardiogenic Shock After Acute Myocardial Infarction. J Am Coll Cardiol. 2018 Jul 10;72(2):173-182. doi: 10.1016/j.jacc.2018.04.051.
PMID: 29976291DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe VIGNON, Dr
CHU Limoges
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2011
First Posted
June 7, 2011
Study Start
September 1, 2011
Primary Completion
February 1, 2016
Study Completion
August 1, 2016
Last Updated
February 1, 2019
Record last verified: 2019-01