Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock (OptimaCC)
Primary Purpose
Cardiogenic Shock
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
epinephrine perfusion
norepinephrine perfusion
Sponsored by
About this trial
This is an interventional treatment trial for Cardiogenic Shock focused on measuring myocardial infarction, epinephrine, norepinephrine, cardiac output
Eligibility Criteria
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
Sites / Locations
- Nancy Brabois university hospital
- CHU de BESANCON / Hôpital Jean Minjoz
- CHU de DIJON
- CHU de LIMOGES Hôpital Dupuytren
- APHM Hôpital NORD
- Chr Metz Thionville
- CH de MULHOUSE
- AP-HP-Hôpital Cochin
- CHU de STRASBOURG / NHC
- CHU Toulouse
- Chru Tours
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
epinephrine
norepinephrine
Arm Description
Outcomes
Primary Outcome Measures
Compared effects of investigated drugs on cardiac index
effectiveness of the treatment assessed by the evolution of cardiac index
Secondary Outcome Measures
pro/anti-inflammatory cytokines
Compared effects of investigated drugs on pro/anti-inflammatory cytokines
BNP
Compared effects of investigated drugs on BNP
Troponin
Compared effects of investigated drugs on Troponin
catecholamine doses
Compared effects of investigated drugs on the catecholamine doses
organ failure (SOFA Score)
Compared effects of investigated drugs on the organ failure
Lactate clearance
Compared effects of investigated drugs on the Lactate clearance
heart rate
Compared effects of investigated drugs on heart rate and the incidence of arrhythmia
cardiac power index
Compared effects of investigated drugs on cardiac power
SVO2
Compared effects of investigated drugs on the SVO2
cardiac double product
Compared effects of investigated drugs on the cardiac double product
refractory cardiogenic shock
compared effects of the investigated drugs on the occurrence of refractory cardiogenic shock
Full Information
NCT ID
NCT01367743
First Posted
May 10, 2011
Last Updated
January 30, 2019
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT01367743
Brief Title
Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock
Acronym
OptimaCC
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock
Keywords
myocardial infarction, epinephrine, norepinephrine, cardiac output
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
epinephrine
Arm Type
Active Comparator
Arm Title
norepinephrine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
epinephrine perfusion
Other Intervention Name(s)
vasopressor, catecholamine
Intervention Description
perfusion of commercial epinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg
Intervention Type
Drug
Intervention Name(s)
norepinephrine perfusion
Other Intervention Name(s)
vasopressor, catecholamine
Intervention Description
perfusion of commercial norepinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg
Primary Outcome Measure Information:
Title
Compared effects of investigated drugs on cardiac index
Description
effectiveness of the treatment assessed by the evolution of cardiac index
Time Frame
H0; H2, H4, H6, H12, H24, H48 and H72
Secondary Outcome Measure Information:
Title
pro/anti-inflammatory cytokines
Description
Compared effects of investigated drugs on pro/anti-inflammatory cytokines
Time Frame
H0, H24, H48 and H72
Title
BNP
Description
Compared effects of investigated drugs on BNP
Time Frame
H0, H24, H48 and H72
Title
Troponin
Description
Compared effects of investigated drugs on Troponin
Time Frame
H0, H24, H48 and H72
Title
catecholamine doses
Description
Compared effects of investigated drugs on the catecholamine doses
Time Frame
H0, H24, H48 and H72
Title
organ failure (SOFA Score)
Description
Compared effects of investigated drugs on the organ failure
Time Frame
H0, H24, H48 and H72
Title
Lactate clearance
Description
Compared effects of investigated drugs on the Lactate clearance
Time Frame
H0, H2, H6, H12, H24 and H48
Title
heart rate
Description
Compared effects of investigated drugs on heart rate and the incidence of arrhythmia
Time Frame
H0, H2, H4, H6, H12, H24, H48 and H72
Title
cardiac power index
Description
Compared effects of investigated drugs on cardiac power
Time Frame
H0, H2, H4, H6, H12, H24, H48 and H72.
Title
SVO2
Description
Compared effects of investigated drugs on the SVO2
Time Frame
H0, H2, H4, H6, H12, H24, H48 and H72.
Title
cardiac double product
Description
Compared effects of investigated drugs on the cardiac double product
Time Frame
H0, H2, H4, H6, H12, H24, H48 and H72.
Title
refractory cardiogenic shock
Description
compared effects of the investigated drugs on the occurrence of refractory cardiogenic shock
Time Frame
H0, H2, H4, H6, H12, H24, H48 and H72.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe VIGNON, Dr
Organizational Affiliation
CHU Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nancy Brabois university hospital
City
Vandoeuvre les Nancy
State/Province
Meurthe Et Moselle
ZIP/Postal Code
54500
Country
France
Facility Name
CHU de BESANCON / Hôpital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU de DIJON
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU de LIMOGES Hôpital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
APHM Hôpital NORD
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Chr Metz Thionville
City
Metz
ZIP/Postal Code
57000
Country
France
Facility Name
CH de MULHOUSE
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Facility Name
AP-HP-Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU de STRASBOURG / NHC
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Facility Name
Chru Tours
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31472039
Citation
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.
Results Reference
derived
PubMed Identifier
29976291
Citation
Levy 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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
http://cic-p-nancy.fr/wp-content/uploads/2019/01/revUS_SAP_OPTIMA_CC_KD_NG.pdf
Learn more about this trial
Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock
We'll reach out to this number within 24 hrs