Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| epinephrine | Active Comparator |
| |
| norepinephrine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epinephrine perfusion | Drug | perfusion of commercial epinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pro/anti-inflammatory cytokines | Compared effects of investigated drugs on pro/anti-inflammatory cytokines | H0, H24, H48 and H72 |
| BNP | Compared effects of investigated drugs on BNP |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philippe VIGNON, Dr | CHU Limoges | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nancy Brabois university hospital | Vandœuvre-lès-Nancy | Meurthe Et Moselle | 54500 | France | ||
| CHU de BESANCON / Hôpital Jean Minjoz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31472039 | Derived | 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. | |
| 29976291 |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| Statistical Analysis Plan | View IPD |
Not provided
Not provided
Not provided
Not provided
Not provided
| norepinephrine perfusion | Drug | perfusion of commercial norepinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg |
|
|
| H0, H24, H48 and H72 |
| Troponin | Compared effects of investigated drugs on Troponin | H0, H24, H48 and H72 |
| catecholamine doses | Compared effects of investigated drugs on the catecholamine doses | H0, H24, H48 and H72 |
| organ failure (SOFA Score) | Compared effects of investigated drugs on the organ failure | H0, H24, H48 and H72 |
| Lactate clearance | Compared effects of investigated drugs on the Lactate clearance | H0, H2, H6, H12, H24 and H48 |
| heart rate | Compared effects of investigated drugs on heart rate and the incidence of arrhythmia | H0, H2, H4, H6, H12, H24, H48 and H72 |
| cardiac power index | Compared effects of investigated drugs on cardiac power | H0, H2, H4, H6, H12, H24, H48 and H72. |
| SVO2 | Compared effects of investigated drugs on the SVO2 | H0, H2, H4, H6, H12, H24, H48 and H72. |
| cardiac double product | Compared effects of investigated drugs on the cardiac double product | H0, H2, H4, H6, H12, H24, H48 and H72. |
| refractory cardiogenic shock | compared effects of the investigated drugs on the occurrence of refractory cardiogenic shock | H0, H2, H4, H6, H12, H24, H48 and H72. |
| 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 |
| 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. |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
Not provided
Not provided
| ID | Term |
|---|---|
| D014662 | Vasoconstrictor Agents |
| D002395 | Catecholamines |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided